Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid
FDA 510(k) clearance K161742 · decided 2016-11-15
Clearance details
- K-number
- K161742
- Device name
- Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid
- Applicant
- Tornier, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2016-06-24
- Decision date
- 2016-11-15
- Days to decision
- 144 days
- Clearance type
- Traditional
- 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 |
|---|---|---|
| TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number DWJ318 recall (Z-1237-2026) | Tornier, Inc | 2026-02-02 |
| stryker Tornier Perform Reversed Augmented Glenoid Lateralized Baseplate, 25mm, Offset +3m recall (Z-0113-2024) | Tornier, Inc | 2023-10-13 |