PRIMA Humeral System and SMR Glenosphere Ø42
FDA 510(k) clearance K212800 · decided 2022-02-25
Clearance details
- K-number
- K212800
- Device name
- PRIMA Humeral System and SMR Glenosphere Ø42
- Applicant
- Lima Corporate S.P.A.
- Decision
- Substantially Equivalent
- Date received
- 2021-09-02
- Decision date
- 2022-02-25
- Days to decision
- 176 days
- Clearance type
- Traditional
- Product code
- PHX
- Device class
- 2
- Regulation number
- 888.3660
- 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 2MM ECCENTRICAL ADAPTOR WITH SCREW REF: 1367.15.702, Sterile recall (Z-2024-2025) | Limacorporate S.p.A | 2025-06-25 |
| PRIMA 4MM ECCENTRICAL ADAPTOR WITH SCREW, REF:1367.15.704, Sterile recall (Z-2025-2025) | Limacorporate S.p.A | 2025-06-25 |