Medical Device Division · registration 160156ExpiredK2M
Hong KongOrthopedic Internal Fixation Systems, SpinalClass IIIK2M, Inc.
Official record identity
- MDACS listing number
- 160156
- Model name
- ARI Anterior Staple System, DENALI Ml Spinal System, DENALI Spinal System, EVEREST Spinal System, MESA Small Stature Spinal System, MESA Spinal System
- Registration date
- May 31, 2021
- Expiry date
- May 31, 2026
- Source update date
- July 07, 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.