Tornier Pyrocarbon Humeral Head
FDA 510(k) clearance DEN220012 · decided 2022-12-16
Clearance details
- K-number
- DEN220012
- Device name
- Tornier Pyrocarbon Humeral Head
- Applicant
- Tornier S.A.S.
- Decision
- Unknown
- Date received
- 2022-02-08
- Decision date
- 2022-12-16
- Days to decision
- 311 days
- Clearance type
- Post-NSE
- Product code
- QKW
- Device class
- 2
- Regulation number
- 888.3695
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Montbonnot-Saint-Martin, FR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.