Medical Device Division · registration 160202ExpiredK2M
Hong KongOrthopedic Internal Fixation Systems, SpinalClass IIIK2M, Inc.
Official record identity
- MDACS listing number
- 160202
- Model name
- NILE Alternative Fixation System (5401-84500, 5401-84500H, 5401-85500, 5401-85500H, 5401-90000, 5401-90001, 5401-90002, 5401-90003, 5401-90005, 5401-90006, 5416-F03730-SG, 5416-F04730-SG)
- Registration date
- May 26, 2021
- Expiry date
- June 21, 2026
- Source update date
- September 19, 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, Spinal
Additional source fields
- AMD nomenclature code
- 15766
- Local responsible person phone
- 39691330
- Published manufacturer address
- 600 Hope Parkway SE, Leesburg, Virginia, 20175, USA
- Published remarks
- Expired.
- Revision number
- d
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.