K2M
Hong KongOrthopedic Internal Fixation Systems, SpinalClass IIIK2M, Inc.
Official record identity
- MDACS listing number
- 150261
- Model name
- Cayman Plate System (1201-16020, 1201-16022, 1201-16024, 1201-16026, 1201-16028, 1201-16030, 1201-16032, 1201-16034, 1201-16036, 1201-16038, 1201-16040, 1201-16042, 1201-16044, 1201-16046, 1201-16048, 1201-16050, 1201-16052, 1201-16054, 1201-17020, 1201-17022, 1201-17024, 1201-17026, 1201-17028, 1201-17030, 1201-17032, 1201-17034, 1201-17036, 1201-17038, 1201-17040, 1201-17042, 1201-17044, 1201-17046, 1201-17048, 1201-17050, 1201-17052, 1201-17054, 1208-41F100, 1208-41F103, 1208-41F106, 1208-41F109, 1208-41F31, 1208-41F32L, 1208-41F32S, 1208-41F34, 1208-41F34L, 1208-41F34S, 1208-41F36L, 1208-41F36S, 1208-41F37, 1208-41F38L, 1208-41F38S, 1208-41F40, 1208-41F40L, 1208-41F40S, 1208-41F42L, 1208-41F42S, 1208-41F43, 1208-41F44L, 1208-41F44S, 1208-41F46, 1208-41F46L, 1208-41F46S, 1208-41F49, 1208-41F52, 1208-41F55, 1208-41F58, 1208-41F61, 1208-41F64, 1208-41F67, 1208-41F70, 1208-41F73, 1208-41F76, 1208-41F79, 1208-41F82, 1208-41F85, 1208-41F88, 1208-41F91, 1208-41F94, 1208-41F97, 1208-42F100, 1208-42F32, 1208-42F34, 1208-42F36, 1208-42F38, 1208-42F40, 1208-42F42, 1208-42F44, 1208-42F46, 1208-42F74, 1208-42F76, 1208-42F80, 1208-42F84, 1208-42F88, 1208-42F92, 1208-42F96, 1408-40F20, 1408-40F22, 1408-40F24, 1408-40F26, 1408-40F28, 1408-40F30, 1208-90000, 1208-90001, 1208-90002, 1208-90003, 1208-90004, 1208-90005, 1208-90007, 1208-90010, 1208-90012, 1208-90014, 1208-90016, 1208-90017, 1208-90029, 1208-90030, 1208-90032, 1208-90033, 1208-90034, 1208-90035, 1208-90036, 1208-90037, 1208-90038, 1208-90039, 1208-90041, 1408-90002, 1408-90003, 1408-90006, K2-12-2008-01, K2-12-2024-01, K2-12-2027-01, K2-12-2030-01, K2-12-2031-01, K2-12-2047-01, K2-12-2048-01, K2-12-2048-02, K2-12-2050-01, K2-12-2051-01, K2-12-2053-01, K2-12-2054-01, K2-12-2055-01, K2-14-2004-01, K2-14-2005-01, K2-98-3066-10, K2-98-3075-10, K298-3086-10)
- Registration date
- August 28, 2015
- Expiry date
- August 28, 2020
- Source update date
- January 01, 2000
- Status
- Expired
Classification
- Risk class
- Class III
Official value: III
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.