Medical Device Division · registration 150262Expired

K2M

Name: K2M — Medical Device Division 150262
Creator: K2M, Inc.
Keywords: K2M, K2M, 150262, Orthopedic Internal Fixation Systems, Spinal, Medical Device Division

Hong KongOrthopedic Internal Fixation Systems, SpinalClass IIIK2M, Inc.

Verified

Official record identity

MDACS listing number: 150262
Model name: Pyrenees Cervical Plate System (201-04010C, 201-04010D, 201-04012C, 201-04012D, 201-04014C, 201-04014D, 201-04016C, 201-04016D, 201-04018C, 201-04018D, 201-04020C, 201-04020D, 201-04022C, 201-04022D, 201-04310C, 201-04312C, 201-04314C, 201-04316C, 201-04318C, 201-04320C, 201-04322C, 201-04510C, 201-04512C, 201-04514C, 201-04516C, 201-04518C, 201-04520C, 201-04522C, 201-14010C, 201-14010D, 201-14012C, 201-14012D, 201-14014C, 201-14014D, 201-14016C, 201-14016D, 201-14018C, 201-14018D, 201-14020C, 201-14022C, 201-14310C, 201-14312C, 201-14314C, 201-14316C, 201-14318C, 201-14320C, 201-14322C, 2201-14522C, 01-14510C, 201-14512C, 201-14514C, 201-14516C, 201-14518C, 201-14520C, 201-41D23, 201-41D24, 201-41D25, 201-41D27, 201-41D29, 201-41D31, 201-41D33, 201-41D35, 201-41D37, 201-41D39, 201-42D36, 201-42D38, 201-42D40, 201-42D42, 201-42D44, 201-42D46, 201-42D48, 201-42D50, 201-42D52, 201-42D54, 201-42D56, 201-43D50, 201-43D53, 201-43D56, 201-43D59, 201-43D62, 201-43D65, 201-43D68, 201-43D71, 201-43D74, 201-43D77, 201-43D80, 201-44D100, 201-44D64, 201-44D68, 201-44D72, 201-44D76, 201-44D80, 201-44D84, 201-44D88, 201-44D92, 201-44D96, 208-41F18, 208-41F20, 208-41F22, 208-41F24, 208-41F26, 208-41F28, 208-41F30, 208-41F32, 208-41F34, 208-41F36, 208-41F38, 208-42F34, 208-42F36, 208-42F38, 208-42F40, 208-42F42, 208-42F44, 208-42F46, 208-42F48, 208-42F50, 208-42F52, 208-42F54, 208-42F56, 208-43F48, 208-43F51, 208-43F54, 208-43F57, 208-43F60, 208-43F63, 208-43F66, 208-43F69, 208-43F72, 208-43F75, 208-43F78, 208-44F101, 208-44F61, 208-44F65, 208-44F69, 208-44F73, 208-44F77, 208-44F81, 208-44F85, 208-44F89, 208-44F93, 208-44F97, 208-45F100, 208-45F105, 208-45F110, 208-45F95, 201-90000, 201-90001, 201-90003, 201-90004, 201-90006, 201-90007, 201-90008, 201-90009, 201-90010, 201-90011, 201-90013, 201-90016, 201-90017, 201-90018, 201-90019, 201-90020, 201-90022, 201-90023, 201-90024, 201-90025, 201-90026, 201-90027, 201-90029, 201-90030, 201-90031, 201-90032, 201-90033, 201-90034, 201-90035, 201-90061, 201-90062, 201-90065, 201-90066, 201-90070, 201-90071, 201-90072, 201-90073, 201-90074, 201-90075, 201-90076, 201-90078, 201-90080, 201-90099, 201-90100, 201-90101, 201-90102, 201-90103, 201-90104, 201-90105, 201-90106, 201-90111, 201-90115, 201-90116, 201-90117, 201-90118, 201-90120, 201-90121, 201-90122, 201-90127, 201-90131, 201-90133, 201-90140, 201-90141, 201-90142, 201-90143, 201-90144, 201-90145, 201-90146, 201-90147, 201-90148, 201-90149, 201-90150, 201-90151, 201-90170, 201-90171, 201-90172, 201-90173, 201-90174, 201-90175, 201-90176, 201-90177, 201-90178, 201-90179, 201-90180, 201-90181, 201-90185, 201-90248, 201-90249, 201-90250, 201-90251, 201-90252, 201-90253, 201-90254, K2-02-2045-01, K2-02-2053-01, K2-02-2071-01, K2-02-2073-01, K2-02-2076-01, K2-02-2163-01, K2-02-2180-01, K2-02-2183-01, K2-02-2189-01, K2-02-2189-09, K2-02-2198-01, K2-02-2199-01, K2-02-2216-01, K2-02-2217-01, K2-02-2218-01, K2-02-2232-01, K2-02-2233-01, K2-02-2260-01, K2-02-2304-01, K2-02-2305-01, K2-02-2306-01, K2-02-2307-01, K2-02-2308-01, K2-02-2309-01, K2-02-2314-01, K2-98-3066-04, K2-98-3070-04, K2-98-3075-04, K2-98-3086-04)
Registration date: August 28, 2015
Expiry date: August 28, 2020
Source update date: January 01, 2000
Status: Expired

Classification

Risk class: Class III
Published category: Orthopedic Internal Fixation Systems, Spinal

Published parties

Registrant / registration holder: Hong Kong and Macau Regulatory Service
Manufacturer: K2M, Inc.

Official description

Orthopedic Internal Fixation Systems, Spinal

Additional source fields

AMD nomenclature code: 15766
Traditional Chinese local responsible person: 香港及澳門法規服務有限公司
Local responsible person phone: 92234360
Published manufacturer address: 751 Miller Drive SE, Leesburg, Virginia 20175, USA
Published remarks: Expired.

About this record

This page mirrors one official MDACS listing. Roman-numeral classes use Hong Kong’s general medical-device scheme, while letter classes use the IVD scheme. Valid, expired, and delisted records remain distinguishable; no mixed classification scale is fabricated.