Identity Shoulder System
510(k) K213856
Identity Shoulder System is a Class II device made by Zimmer, Inc., cleared under FDA 510(k) K213856 on 15 Sep 2022, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK213856 | Date15 Sep 2022 | StatusActive |
Official records
- FDA 510(k) database K213856
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MBF
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3670
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent