Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed Glenoid
FDA 510(k) clearance K183696 · decided 2019-01-30
Clearance details
- K-number
- K183696
- Device name
- Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed Glenoid
- Applicant
- Tornier, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2018-12-31
- Decision date
- 2019-01-30
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- PHX
- Device class
- 2
- Regulation number
- 888.3660
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Bloomington, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Stryker Tornier Perform Reversed Glenoid Press-Fit Short Post Ti6AI4V, REF DWJ001, L: 7mm, recall (Z-0773-2024) | Tornier, Inc | 2024-01-19 |