Medical Device Division · registration 150303ExpiredK2M
Hong KongProsthesis Implantation Instruments, OrthopedicClass IIK2M, Inc.
Official record identity
- MDACS listing number
- 150303
- Model name
- Serengeti MI Retractor System (1001-90112-SG, 1001-90113-SG, 1001-90122, 1001-90123, 1001-90128, 1001-90129, 1001-90157, 1001-90160, 1001-90162, 1001-90183, 1001-90185, 1001-90187, K2-10-2196-01, K2-10-2198-01, K2-10-2209-01, K2-10-2211-01, K2-10-2215-01, k2-10-2100-01)
- Registration date
- September 24, 2015
- Expiry date
- September 24, 2020
- Source update date
- August 25, 2016
- Status
- Expired
Classification
- Risk class
- Class II
Official value: II
Published parties
- Registrant / registration holder
- Hong Kong and Macau Regulatory Service
- Manufacturer
- K2M, Inc.
Official description
Prosthesis Implantation Instruments, Orthopedic
Additional source fields
- AMD nomenclature code
- 13180
- 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, Suite F-1, 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.