OMNIFIT TOTAL KNEE SERIES II TIBIAL INSERTS
FDA 510(k) clearance K884398 · decided 1989-01-17
Clearance details
- K-number
- K884398
- Device name
- OMNIFIT TOTAL KNEE SERIES II TIBIAL INSERTS
- Applicant
- Osteonics Corp.
- Decision
- Substantially Equivalent for Some Indications
- Date received
- 1988-10-19
- Decision date
- 1989-01-17
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- JWH
- Device class
- 2
- Regulation number
- 888.3560
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Allendale, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| SERIES II TIBIAL BEAR INSERT-Intended for knee replacement Part Number: 3052-0515 recall (Z-0873-2024) | Howmedica Osteonics Corp. | 2024-01-31 |
| SERIES II TIBIAL BEAR INSERT-Intended for knee replacement Part Number: 3052-0524 recall (Z-0874-2024) | Howmedica Osteonics Corp. | 2024-01-31 |