Aequalis Shoulder Prosthesis
by Tornier
510(k) K980244
Aequalis Shoulder Prosthesis is a Class II device made by Tornier, cleared under FDA 510(k) K980244 on 23 Aug 1999, 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 | NumberK980244 | Date23 Aug 1999 | StatusActive |
Official records
- FDA 510(k) database K980244
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KWS
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3660
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent