160093
Orthopedic Internal Fixation Systems, Spinal
骨科内固定系统,脊柱
K2M, Inc.·III·Hong Kong MDACS·Registered March 21, 2021
Device overview
- Risk class
- III
- Product code
- 15766
- State
- current
- Status
- N/A
- Product code detail
- 15766 Orthopedic Internal Fixation Systems, Spinal
Manufacturer (製造商)
- Name
- K2M, Inc.K2M (Va)
- Country
- United States美国
- Address
- 600 Hope Parkway SE, Leesburg, Virginia 20175 USA600 希望大路东南, 利斯堡, 弗吉尼亚州 20175 美国
Authorised representative (AR)
- Name
- Stryker China Limited美国史赛克(中国)有限公司
- Phone
- 39691200
Regulatory timeline
- Registration date
- March 21, 2021
- Expiry date
- March 21, 2026
Product models
CASPIAN Spinal System (1101-03510F, 1101-03510M, 1101-03510MC, 1101-03512, 1101-03512F, 1101-03512M, 1101-03512MC, 1101-03514, 1101-03514F, 1101-03514M, 1101-03514MC, 1101-03516, 1101-03516F, 1101-03516FL, 1101-03516M, 1101-03516MC, 1101-03516ML, 1101-03518, 1101-03518F, 1101-03518FL, 1101-03518M, 1101-03518MC, 1101-03518ML, 1101-03520, 1101-03520F, 1101-03520FL, 1101-03520M, 1101-03520MC, 1101-03520ML, 1101-03522F, 1101-03522FL, 1101-03522M, 1101-03522MC, 1101-03522ML, 1101-03524F, 1101-03524FL, 1101-03524M, 1101-03524MC, 1101-03524ML, 1101-03525, 1101-03525F, 1101-03525M, 1101-03526F, 1101-03526FL, 1101-03526M, 1101-03526MC, 1101-03526ML, 1101-03528F, 1101-03528FL, 1101-03528M, 1101-03528MC, 1101-03528ML, 1101-03530, 1101-03530F, 1101-03530FL, 1101-03530M, 1101-03530MC, 1101-03530ML, 1101-03532F, 1101-03532FL, 1101-03532M, 1101-03532MC, 1101-03532ML, 1101-03534F, 1101-03534FL, 1101-03534M, 1101-03534MC, 1101-03534ML, 1101-03535, 1101-03535F, 1101-03535M, 1101-03536F, 1101-03536FL, 1101-03536M, 1101-03536MC, 1101-03536ML, 1101-03538F, 1101-03538FL, 1101-03538M, 1101-03538MC, 1101-03538ML, 1101-03540, 1101-03540F, 1101-03540FL, 1101-03540M, 1101-03540MC, 1101-03540ML, 1101-03545, 1101-03545F, 1101-03545M, 1101-03545MC, 1101-03550, 1101-03550F, 1101-03550M, 1101-03550MC, 1101-04010, 1101-04010F, 1101-04010M, 1101-04010MC, 1101-04012, 1101-04012F, 1101-04012M, 1101-04012MC, 1101-04014, 1101-04014F, 1101-04014M, 1101-04014MC, 1101-04016, 1101-04016F, 1101-04016FL, 1101-04016M, 1101-04016MC, 1101-04016ML, 1101-04018, 1101-04018F, 1101-04018FL, 1101-04018M, 1101-04018MC, 1101-04018ML, 1101-04020, 1101-04020F, 1101-04020FL, 1101-04020M, 1101-04020MC, 1101-04020ML, 1101-04022F, 1101-04022FL, 1101-04022M, 1101-04022MC, 1101-04022ML, 1101-04024F, 1101-04024FL, 1101-04024M, 1101-04024MC, 1101-04024ML, 1101-04025, 1101-04025F, 1101-04025M, 1101-04026F, 1101-04026FL, 1101-04026M, 1101-04026MC, 1101-04026ML, 1101-04028F, 1101-04028FL, 1101-04028M, 1101-04028MC, 1101-04028ML, 1101-04030, 1101-04030F, 1101-04030FL, 1101-04030M, 1101-04030MC, 1101-04030ML, 1101-04032F, 1101-04032FL, 1101-04032M, 1101-04032MC, 1101-04032ML, 1101-04034F, 1101-04034FL, 1101-04034M, 1101-04034MC, 1101-04034ML, 1101-04035, 1101-04035F, 1101-04035M, 1101-04036F, 1101-04036FL, 1101-04036M, 1101-04036MC, 1101-04036ML, 1101-04038F, 1101-04038FL, 1101-04038M, 1101-04038MC, 1101-04038ML, 1101-04040, 1101-04040F, 1101-04040FL, 1101-04040M, 1101-04040MC, 1101-04040ML, 1101-04045, 1101-04045F, 1101-04045M, 1101-04045MC, 1101-04050, 1101-04050F, 1101-04050M, 1101-04050MC, 1101-04510F, 1101-04510M, 1101-04510MC, 1101-04512F, 1101-04512M, 1101-04512MC, 1101-04514F, 1101-04514M, 1101-04514MC, 1101-04516F, 1101-04516M, 1101-04516MC, 1101-04518F, 1101-04518M, 1101-04518MC, 1101-04520F, 1101-04520M, 1101-04520MC, 1101-04522F, 1101-04522M, 1101-04522MC, 1101-04524F, 1101-04524M, 1101-04524MC, 1101-04526F, 1101-04526M, 1101-04526MC, 1101-04528F, 1101-04528M, 1101-04528MC, 1101-04530F, 1101-04530M, 1101-04530MC, 1101-04532F, 1101-04532M, 1101-04532MC, 1101-04534F, 1101-04534M, 1101-04534MC, 1101-04536F, 1101-04536M, 1101-04536MC, 1101-04538F, 1101-04538M, 1101-04538MC, 1101-04540F, 1101-04540M, 1101-04540MC, 1101-04545F, 1101-04545M, 1101-04545MC, 1101-04550F, 1101-04550M, 1101-04550MC, 1101-10001, 1101-10002, 1101-10003, 1101-10004, 1101-10005, 1101-14506, 1101-14507, 1101-14508, 1101-14509, 1101-14510, 1101-14511, 1101-14512, 1101-14513, 1101-14514, 1101-14515, 1101-14516, 1101-15206, 1101-15207, 1101-15208, 1101-15209, 1101-15210, 1101-15211, 1101-15212, 1101-15213, 1101-15214, 1101-15215, 1101-15216, 1101-40001, 1101-40002, 1101-42540, 1101-42550, 1101-535120, 1101-535240, 1101-535300-55, 1101-535500-55, 1101-53580, 1101-635110-115, 1101-635110-130, 1101-635200-115, 1101-635200-130, 1101-70001, 1101-70002, 1101-70003, 1101-72631, 1101-72631L, 1101-72631M, 1101-73038, 1101-73038L, 1101-73038M, 1101-73510, 1101-73747, 1101-73747L, 1101-73747M, 1101-74658, 1101-74658L, 1101-74658M, 1101-83501, 1101-83502, 1101-83503, 1101-83504, 1101-83505, 1101-83506, 1101-83507, 1101-83508, 1101-83509, 1101-83510, 1101-83511, 1101-83513, 1101-83514, 1101-83515, 1101-83516, 1101-83517, 1101-83518, 1101-83535, 1101-83535D, 1101-83555, 1101-83555D, 1101-85555, 1101-90001, 1101-90002, 1101-90003, 1101-90005, 1101-90006, 1101-90007, 1101-90008, 1101-90012, 1101-90013, 1101-90014, 1101-90015, 1101-90016, 1101-90017, 1101-90018, 1101-90019, 1101-90020, 1101-90021, 1101-90022, 1101-90023, 1101-90024, 1101-90025, 1101-90026, 1101-90027, 1101-90029, 1101-90030, 1101-90031, 1101-90032, 1101-90033, 1101-90034, 1101-90037, 1101-90039, 1101-90040, 1101-90041, 1101-90042, 1101-90043, 1101-90044, 1101-90045, 1101-90046, 1101-90051, 1101-90052, 1101-90053, 1101-90054, 1101-90058, 1101-90059, 1101-90061, 1101-90062, 1101-90063, 1101-90067, 1101-90068, 1101-90069, 1101-90104, 1101-90116, 1101-90122, 1101-90123, 1101-90124, 1101-90125, 1101-90126, 1101-90127, 1101-90128, 1101-90129, 1101-90131, 1101-90132, 1101-90133, 1101-90134, 1101-90135, 1101-90136, 1101-90137, 1101-90155, 1101-90156, 1101-90157, 1101-90168, 1101-90186, 1101-90195, 1101-90196, 1101-90197, 1101-90198, 1101-90201, 1101-90203, 1101-90205, 1101-90211, 1101-90212, 1101-90213, 1101-90215, 1101-90216, 1101-90217, 1101-90218, 1101-90219, 1101-90220, 1101-90221, 1101-90222, 1101-90223, 1101-90224, 1101-90225, 1101-90226, 1101-90227, 1101-90228, 1101-90229, 1101-90230, 1101-90231, 1101-90232, 1101-90233, 1101-90234, 1101-90235, 1101-90236, 1101-90237, 1101-90238, 1101-90239, 1101-90240, 1101-90241, 1101-90242, 1101-90243, 1101-90244, 1101-90245, 1101-90246, 1101-90255, 1101-90256, 1101-90273, 1101-90274, 1101-90275, 1101-90277, 1101-90279, 1101-90308, 1101-90310, 1101-90311, 1101-90312, 1111-535300-55, 1111-535500-55, 1111-B35200, 1111-B35300, 1111-B35400, 1111-B35500, 1111-B35550, 1111-B35600, 1111-G01610, K2-11-2000-01, K2-11-2007-01, K2-11-2019-01, K2-11-2021-01, K2-11-2022-01, K2-11-2023-01, K2-11-2024-01, K2-11-2026-01, K2-11-2027-01, K2-11-2028-01, K2-11-2029-01, K2-11-2030-01, K2-11-2031-01, K2-11-2032-01, K2-11-2035-01, K2-11-2037-01, K2-11-2038-01, K2-11-2040-01, K2-11-2041-01, K2-11-2042-01, K2-11-2044-01, K2-11-2047-01, K2-11-2048-01, K2-11-2049-01, K2-11-2051-01, K2-11-2052-01, K2-11-2053-01, K2-11-2053-02, K2-11-2054-01, K2-11-2055-02, K2-11-2055-03, K2-11-2055-06, K2-11-2056-01, K2-11-2057-01, K2-11-2058-01, K2-11-2059-01, K2-11-2078-01, K2-11-2079-01, K2-11-2082-01, K2-11-2083-01, K2-11-2084-01, K2-11-2091-01, K2-11-2097-01, K2-11-2097-02, K2-11-2109-01, K2-11-2111-01, K2-11-2112-01, K2-11-2118-01, K2-11-2129-01, K2-11-2129-02, K2-11-2129-03, K2-11-2129-04, K2-11-2129-05, K2-11-2129-06, K2-11-2141-01, K2-11-2174-01, K2-11-2177-01, K2-11-2177-02, K2-11-2179-01, K2-11-2180-01, K2-11-2183-01, K2-11-2183-02, K2-11-2184-01, K2-11-2186-01, K2-11-2202-01, K2-11-2205-01, K2-11-2206-01, K2-11-2207-01, K2-11-2209-01, K2-11-2210-01, K2-11-2211-01, K2-11-2212-01, K2-11-2212-02, K2-11-2212-03, K2-11-2213-01, K2-11-2213-02, K2-11-2214-01, K2-11-2215-01, K2-11-2216-01, K2-11-2219-01, K2-11-2219-02, K2-11-2224-01, K2-11-2229-01, K2-11-2230-01, K2-11-2231-01, K2-11-2232-01, K2-11-2233-01, K2-11-2234-01, K2-11-2235-01, K2-11-2236-01, K2-11-2236-02, K2-11-2237-01, K2-11-2238-01, K2-11-2239-01, K2-11-2240-01, K2-11-2257-01, K2-11-2257-02, K2-11-2258-01, K2-11-2259-01, K2-11-2260-01, K2-11-2261-01, K2-11-2261-02, K2-11-2261-03, K2-11-2262-01, K2-11-2263-01, K2-11-2273-01, K2-11-2277-01, K2-11-2278-01, K2-11-2279-01, K2-11-2290-01, K2-11-2297-01, 1101-03510, 1101-42530, 1101-635125-115, 1101-635125-130, 1101-635215-115, 1101-635215-130, 1101-90066, 1101-90200, 1101-90202, 1101-90314, 1101-90318, 1101-90319, 1111-635125-115, 1111-635125-130, 1111-635215-115, 1111-635215-130, K2-11-2203-01)
里海脊柱系统(1101-03510F, 1101-03510M, 1101-03510MC, 1101-03512, 1101-03512F, 1101-03512M, 1101-03512MC, 1101-03514, 1101-03514F, 1101-03514M, 1101-03514MC, 1101-03516, 1101-03516F, 1101-03516FL, 1101-03516M, 1101-03516MC, 1101-03516ML, 110101-03 516ML -03518, 1101-03518F, 1101-03518FL, 1101-03518M, 1101-03518MC, 1101-03518ML, 1101-03520, 1101-03520F, 1101-03520FL, 1101-03520M, 1101-03520MC, 1101-03520ML, 1101-03522F, 1101-03522FL, 1101-03522M, 1101-03522MC, 1101-03522ML, 1101-03524F, 1101-03524FL, 1101-03524M, 1101-03524MC, 1101-03524ML, 1101-03525, 1101-03525F, 1101-03525M, 1101-03526F, 1101-03526FL, 1101-03526M, 1101-03526MC, 1101-03526ML, 1101-03528F, 1101-03528FL, 1101-03528M, 1101-03528MC, 1101-03528ML, 1101-03530, 1101-03530, 1101-03530, 1101-03530, 1 101-03530 101-03530F, 1101-03530FL, 1101-03530M, 1101-03530MC, 1101-03530ML, 1101-03532F, 1101-03532FL, 1101-03532M, 1101-03532MC, 1101-03532ML, 1101-03534F, 1101-03534FL, 1101-03534M, 1101-03534MC, 1101-03534ML, 1101-03535, 1101-03535F, 1101-03535M,1101-03536F, 1101-03536FL, 1101-03536M, 1101-03536MC, 1101-03536ML, 1101-03538F, 1101-03538FL, 1101-03538M, 1101-03538MC, 1101-03538ML, 1101-03540, 1101-03540F, 1101-03540FL, 1101-03540M, 1101-03540MC, 1101-03540ML, 1101-03545, 1101-03545F, 1101-03545M, 1101-03545MC, 1101-03550, 1101-03550F, 1101-03550M, 1101-03550MC, 1101-04010, 1101-04010F, 1101-04010M, 1101-04010MC, 1101-04012, 1101-04012F, 1101-04012M, 1101-04012MC, 1101-04014, 1101-04014F, 1101-04014M, 1101-04014MC, 1101-04016, 1101-04016F, 1101-04016FL, 1101-04016M, 1101-04016MC, 1101-04016ML, 1101-04018, 1101-04018F, 1101-04018FL, 1101-04018M, 1101-04018MC, 1101-04018ML, 1101-04020F, 1101-04020FL, 1101-04020M, 1101-04020MC, 1101-04020ML, 1101-04022F, 1101-04022F, 1101-04022F, 1101-04022F, 1101-04022F, 1101-04020FL, 1101-04020M 101-04022FL, 1101-04022M, 1101-04022MC, 1101-04022ML, 1101-04024F, 1101-04024FL, 1101-04024M, 1101-04024MC, 1101-04024ML, 1101-04025, 1101-04025F, 1101-04025M, 1101-04026F, 1101-04026FL, 1101-04026M, 1101-04026MC, 1101-04026ML, 1101-04028F,1101-04028FL, 1101-04028M, 1101-04028MC, 1101-04028ML, 1101-04030, 1101-04030F, 1101-04030FL, 1101-04030M, 1101-04030MC, 1101-04030ML, 1101-04032F, 1101-04032FL, 1101-04032M, 1101-04032MC, 1101-04032ML, 1101-04034F, 1101-04034FL, 1101-04034M, 1101-04034MC, 1101-04034ML, 1101-04035, 1101-04035F, 1101-04035M, 1101-04036F, 1101-04036FL, 1101-04036M, 1101-04036MC, 1101-04036ML, 1101-04038F, 1101-04038FL, 1101-04038M, 1101-04038MC, 1101-04038ML, 1101-04040, 1101-04040F, 1101-04040FL,1101-04040M, 1101-04040MC, 1101-04040ML, 1101-04045, 1101-04045F, 1101-04045M, 1101-04045MC, 1101-04050, 1101-04050F, 1101-04050M, 1101-04050MC, 1101-04510F, 1101-04510M, 1101-04510MC, 1101-04512F, 1101-04512M, 1101-04512MC, 1101-04514F, 1101-04514F, 1101-04514F 01-04514M, 1101-04514MC, 1101-04516F, 1101-04516M, 1101-04516MC, 1101-04518F, 1101-04518M, 1101-04518MC, 1101-04520F, 1101-04520M, 1101-04520MC, 1101-04522F, 1101-04522M, 1101-04522MC, 1101-04524F, 1101-04524M, 1101-04524MC, 1101-04526F,1101-04526M, 1101-04526MC, 1101-04528F, 1101-04528M, 1101-04528MC, 1101-04530F, 1101-04530M, 1101-04530MC, 1101-04532F, 1101-04532M, 1101-04532MC, 1101-04534F, 1101-04534M, 1101-04534MC, 1101-04536F, 1101-04536M, 1101-04536MC, 1101-04538F, 110101 0-04538F, 11010-04534MC, 1101-04536M, 1101-04538F, 11010-04538F, 1101-04534MC, 1101-04536F, 1101-04538F, 1101-04534MC, 1101-04536F, 1101-04538F, 1101-04534MC, 1101-04536F, 1101-04538F, 1101-04534MC, 1101-04536M, 1101-04536MC, 1101-04538F, 110101 -04538F, 1101-04534MC, 1101-04536F, 1101-04536M, 1101-04536MC, 1101-04538F, 1101-04538F, 1101-04536M, 1101-04538F, 1101-04534MC, 1101-04536F, 1101-04536M, 1101-04536MC, 1101-04536MC, 1101-04538F, 1101-04534MC, 1101-04536M, 1101-04536M, 1101-04536M, 1101-04436M, 1101-04436M, 1101-04436M, 1101-04536M, 1101-04436M, 1101-04436M, 1101-04436M, 1101-04436M, 1101-04436M, 1101-04436M, 1101-04536M, 1101-04436M, 1101-04436M, 1101-04436M, 1101-04536M, 1101-04436M, 1101-04436M 51-04538M, 1101-04538MC, 1101-04540F, 1101-04540M, 1101-04540MC, 1101-04545F, 1101-04545M, 1101-04545MC, 1101-04550F, 1101-04550M, 1101-04550MC, 1101-10001, 1101-10002, 1101-10003, 1101-10004, 1101-10005, 1101-14506, 1101-14507, 1101-14508,1101-14509, 1101-14510, 1101-14511, 1101-14512, 1101-14513, 1101-14514, 1101-14515, 1101-14516, 1101-15206, 1101-15207, 1101-15208, 1101-15209 , 1101-15210, 1101-15211, 1101-15212, 1101-15213, 1101-15214, 1101-15215, 1101-15216, 1101-40001, 1101-40001, 1101-444101-415214, 1101-15215 , 1101-15216, 1101-40001, 1101-440001 0002, 1101-42540, 1101-42550, 1101-535120, 1101-535240, 1101-535300-55, 1101-535500-55, 1101-53580, 110101-53580, 1100 1-635110-115, 1101-635110-130, 1101-635200-115, 1101-635200-130, 1101-70001, 1101-70002, 1101-70003, 1101-72631, 1101-72631L, 1101-72631M,1101-73038, 1101-73038L, 1101-73038M, 1101-73510, 1101-73747, 1101-73747L, 1101-73747M, 1101-74658, 1101-74658L, 1101-74658M, 1101-83501, 1101-83502, 1101-83503, 1101-83504, 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About this record
This profile provides complete Hong Kong MDACS registration information for Orthopedic Internal Fixation Systems, Spinal. Review device classification, authorised representative (AR) details, manufacturer contacts, product codes, and regulatory milestones. Pure Global AI delivers bilingual transparency for medical device registrations across Asia.
Product Info: Orthopedic Internal Fixation Systems, Spinal
產品資訊： 骨科内固定系统,脊柱