Medical Device Division · registration 140424ExpiredK2M
Hong KongOrthopedic Internal Fixation SystemsClass IIIK2M, Inc.
Official record identity
- MDACS listing number
- 140424
- Model name
- Blue Ridge Cervical Plate System (3901-04010C, 3901-04010D, 3901-04012C, 3901-04012D, 3901-04014C, 3901-04014D, 3901-04016C, 3901-04016D, 3901-04018C, 3901-04018D, 3901-04020C, 3901-04020D, 3901-04022C, 3901-04022D, 3901-04310C, 3901-04310D, 3901-04312C, 3901-04312D, 3901-04314C, 3901-04314D, 3901-04316C, 3901-04316D, 3901-04318C, 3901-04318D, 3901-04320C, 3901-04322C, 3901-04322D, 3901-04510C, 3901-04510D, 3901-04512C, 3901-04512D, 3901-04514C, 3901-04514D, 3901-04516C, 3901-04516D, 3901-04518C, 3901-04518D, 3901-04520C, 3901-04520D, 3901-04522C, 3901-04522D, 3901-14010C, 3901-14010D, 3901-14012C, 3901-14012D, 3901-14014C, 3901-14014D, 3901-14016C, 3901-14016D, 3901-14018C, 3901-14018D, 3901-14020C, 3901-14022C, 3901-14310C, 3901-14310D, 3901-14312C, 3901-14312D, 3901-14314C, 3901-14314D, 3901-14316C, 3901-14316D, 3901-14318C, 3901-14318D, 3901-14320C, 3901-14322C, 3901-14510C, 3901-14512C, 3901-14514C, 3901-14516C, 3901-14518C, 3901-14520C, 3901-14522C, 3901-90015, 3901-90016, 3901-90018, 3901-90019, 3901-90020, 3901-90021, 3901-90022, 3901-90023, 3901-90024, 3901-90025, 3901-90026, 3901-90027, 3901-90028, 3901-90029, 3901-90030, 3901-90031, 3901-90032, 3901-90033, 3901-90038, 3901-90039, 3901-90040, 3901-90041, 3901-90046, 3914-41F22, 3914-41F22A, 3914-41F23, 3914-41F23A, 3914-41F24, 3914-41F24A, 3914-41F25, 3914-41F25A, 3914-41F26, 3914-41F26A, 3914-41F27, 3914-41F27A, 3914-41F28, 3914-41F28A, 3914-41F29, 3914-41F29A, 3914-41F30, 3914-41F30A, 3914-41F31, 3914-41F31A, 3914-41F32, 3914-41F32A, 3914-41F33, 3914-41F33A, 3914-41F34, 3914-41F34A, 3914-41F35, 3914-41F35A, 3914-41F36, 3914-41F36A, 3914-41F37, 3914-41F37A, 3914-41F38, 3914-41F38A, 3914-42F34, 3914-42F34A, 3914-42F35, 3914-42F35A, 3914-42F36, 3914-42F36A, 3914-42F37, 3914-42F37A, 3914-42F38, 3914-42F38A, 3914-42F39, 3914-42F39A, 3914-42F40, 3914-42F40A, 3914-42F41, 3914-42F41A, 3914-42F42, 3914-42F42A, 3914-42F43, 3914-42F43A, 3914-42F44, 3914-42F44A, 3914-42F45, 3914-42F45A, 3914-42F46, 3914-42F46A, 3914-42F47, 3914-42F47A, 3914-42F48, 3914-42F48A, 3914-42F49, 3914-42F49A, 3914-42F50, 3914-42F50A, 3914-42F51, 3914-42F51A, 3914-42F52, 3914-42F52A, 3914-42F53, 3914-42F53A, 3914-42F54, 3914-42F54A, 3914-42F55, 3914-42F55A, 3914-42F56, 3914-42F56A, 3914-43F45, 3914-43F45A, 3914-43F46, 3914-43F46A, 3914-43F47, 3914-43F47A, 3914-43F48, 3914-43F48A, 3914-43F49, 3914-43F49A, 3914-43F50, 3914-43F50A, 3914-43F51, 3914-43F51A, 3914-43F52, 3914-43F52A, 3914-43F53, 3914-43F53A, 3914-43F54, 3914-43F54A, 3914-43F55, 3914-43F55A, 3914-43F56, 3914-43F56A, 3914-43F57, 3914-43F57A, 3914-43F58, 3914-43F58A, 3914-43F59, 3914-43F59A, 3914-43F60, 3914-43F60A, 3914-43F61, 3914-43F61A, 3914-43F62, 3914-43F62A, 3914-43F63, 3914-43F63A, 3914-43F64, 3914-43F64A, 3914-43F65, 3914-43F65A, 3914-43F66, 3914-43F66A, 3914-43F67, 3914-43F67A, 3914-43F68, 3914-43F68A, 3914-43F69, 3914-43F69A, 3914-43F70, 3914-43F70A, 3914-43F71, 3914-43F71A, 3914-43F72, 3914-43F72A, 3914-43F73, 3914-43F73A, 3914-43F74, 3914-43F74A, 3914-43F75, 3914-43F75A, 3914-43F76, 3914-43F76A, 3914-43F77, 3914-43F77A, 3914-43F78, 3914-43F78A, 3914-44F100, 3914-44F100A, 3914-44F101, 3914-44F101A, 3914-44F57, 3914-44F57A, 3914-44F58, 3914-44F58A, 3914-44F59, 3914-44F59A, 3914-44F60, 3914-44F60A, 3914-44F61, 3914-44F61A, 3914-44F62, 3914-44F62A, 3914-44F63, 3914-44F63A, 3914-44F64, 3914-44F64A, 3914-44F65, 3914-44F65A, 3914-44F66, 3914-44F66A, 3914-44F67, 3914-44F67A, 3914-44F68, 3914-44F68A, 3914-44F69, 3914-44F69A, 3914-44F70, 3914-44F70A, 3914-44F71, 3914-44F71A, 3914-44F72, 3914-44F72A, 3914-44F73, 3914-44F73A, 3914-44F74, 3914-44F74A, 3914-44F75, 3914-44F75A, 3914-44F76, 3914-44F76A, 3914-44F77, 3914-44F77A, 3914-44F78, 3914-44F78A, 3914-44F79, 3914-44F79A, 3914-44F80, 3914-44F80A, 3914-44F81, 3914-44F81A, 3914-44F82, 3914-44F82A, 3914-44F83, 3914-44F83A, 3914-44F84, 3914-44F84A, 3914-44F85, 3914-44F85A, 3914-44F86, 3914-44F86A, 3914-44F87, 3914-44F87A, 3914-44F88, 3914-44F88A, 3914-44F89, 3914-44F89A, 3914-44F90, 3914-44F90A, 3914-44F91, 3914-44F91A, 3914-44F92, 3914-44F92A, 3914-44F93, 3914-44F93A, 3914-44F94, 3914-44F94A, 3914-44F95, 3914-44F95A, 3914-44F96, 3914-44F96A, 3914-44F97, 3914-44F97A, 3914-44F98, 3914-44F98A, 3914-44F99, 3914-44F99A, 3914-45F100, 3914-45F100A, 3914-45F101, 3914-45F101A, 3914-45F102, 3914-45F102A, 3914-45F103, 3914-45F103A, 3914-45F104, 3914-45F104A, 3914-45F105, 3914-45F105A, 3914-45F106, 3914-45F106A, 3914-45F107, 3914-45F107A, 3914-45F108, 3914-45F108A, 3914-45F109, 3914-45F109A, 3914-45F110, 3914-45F110A, 3914-45F80, 3914-45F80A, 3914-45F81, 3914-45F81A, 3914-45F82, 3914-45F82A, 3914-45F83, 3914-45F83A, 3914-45F84, 3914-45F84A, 3914-45F85, 3914-45F85A, 3914-45F86, 3914-45F86A, 3914-45F87, 3914-45F87A, 3914-45F88, 3914-45F88A, 3914-45F89, 3914-45F89A, 3914-45F90, 3914-45F90A, 3914-45F91, 3914-45F91A, 3914-45F92, 3914-45F92A, 3914-45F93, 3914-45F93A, 3914-45F94, 3914-45F94A, 3914-45F95, 3914-45F95A, 3914-45F96, 3914-45F96A, 3914-45F97, 3914-45F97A, 3914-45F98, 3914-45F98A, 3914-45F99, 3914-45F99A), Pyrenees Cervical Plate System (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, 201-14510C, 201-14512C, 201-14514C, 201-14516C, 201-14518C, 201-14520C, 201-14522C, 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, 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, 201-90078, 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, 201-90248, 201-90249, 201-90251, 201-90254, 201-90259, 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, 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, K2-02-2305-01, K2-02-2306-01, K2-02-2307-01, K2-02-2308-01, K2-02-2314-01, K2-02-2328-01)
- Registration date
- December 09, 2020
- Expiry date
- January 30, 2025
- Source update date
- July 11, 2023
- Status
- Expired
Classification
- Risk class
- Class III
Official value: III
Published parties
- Registrant / registration holder
- Stryker China Limited
- Manufacturer
- K2M, Inc.
Official description
Orthopedic Internal Fixation Systems
Additional source fields
- AMD nomenclature code
- 16027
- Local responsible person phone
- 39691330
- Published manufacturer address
- 600 Hope Parkway SE, Leesburg, Virginia 20175 USA
- Published remarks
- Expired.
- Revision number
- e
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.