PRIMA TT Glenoid
FDA 510(k) clearance K222427 · decided 2022-10-06
Clearance details
- K-number
- K222427
- Device name
- PRIMA TT Glenoid
- Applicant
- Lima Corporate S.P.A.
- Decision
- Substantially Equivalent
- Date received
- 2022-08-11
- Decision date
- 2022-10-06
- Days to decision
- 56 days
- Clearance type
- Traditional
- Product code
- MBF
- Device class
- 2
- Regulation number
- 888.3670
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Villanova Di San Daniele Del Friuli, IT
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| PRIMA TT Glenoid Monoblock/Modular reverse TT baseplates: Description/Product Code: BASEPL recall (Z-0726-2024) | Limacorporate S.p.A | 2024-01-12 |
| REF 1975.14.500, Prima TT Genoid Monoblock Reverse TT Baseplate, STERILE R recall (Z-2009-2023) | Limacorporate S.p.A | 2023-06-27 |
| REF 1975.14.800, Prima TT Genoid Modular Reverse TT Baseplate, Sterile R recall (Z-2010-2023) | Limacorporate S.p.A | 2023-06-27 |