Aequalis Shoulder System
510(k) K063081
Aequalis Shoulder System is a Class II device made by Tornier, cleared under FDA 510(k) K063081 on 9 Nov 2006, 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 | NumberK063081 | Date9 Nov 2006 | StatusActive |
Official records
- FDA 510(k) database K063081
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- HSD
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3690
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent