PERFORM Humeral System – Stem
FDA 510(k) clearance K201315 · decided 2020-09-11
Clearance details
- K-number
- K201315
- Device name
- PERFORM Humeral System – Stem
- Applicant
- Tornier, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2020-05-18
- Decision date
- 2020-09-11
- Days to decision
- 116 days
- Clearance type
- Traditional
- Product code
- PAO
- 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 Humeral System, Reversed Insert, 45%, REF DWP2393, for shoulder ar recall (Z-3309-2024) | Tornier, Inc | 2024-09-27 |