Physica system
FDA 510(k) clearance K213381 · decided 2021-12-17
Clearance details
- K-number
- K213381
- Device name
- Physica system
- Applicant
- Lima Corporate S.P.A.
- Decision
- Substantially Equivalent
- Date received
- 2021-10-13
- Decision date
- 2021-12-17
- Days to decision
- 65 days
- Clearance type
- Traditional
- Product code
- JWH
- Device class
- 2
- Regulation number
- 888.3560
- 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 |
|---|---|---|
| PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610 recall (Z-0524-2024) | Limacorporate S.p.A | 2023-12-09 |