Aequalis Ascend Modular Reverse Shoulder System
510(k) K110599
Aequalis Ascend Modular Reverse Shoulder System is a Class II device made by Tornier, Inc., cleared under FDA 510(k) K110599 on 14 Jun 2011, 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 | NumberK110599 | Date14 Jun 2011 | StatusActive |
Official records
- FDA 510(k) database K110599
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- PHX
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3660
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent