OSTEONICS RESTORATION ACETABULAR RING
FDA 510(k) clearance K970957 · decided 1997-06-03
Clearance details
- K-number
- K970957
- Device name
- OSTEONICS RESTORATION ACETABULAR RING
- Applicant
- Osteonics Corp.
- Decision
- Substantially Equivalent
- Date received
- 1997-03-17
- Decision date
- 1997-06-03
- Days to decision
- 78 days
- Clearance type
- Traditional
- Product code
- JDJ
- Device class
- 2
- Regulation number
- 878.3300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Allendale, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| LINK, ACETABULAR REVISION MESH CUP (K972760) | Link America, Inc. | 1997-10-22 |
| EXETER MESH (K963940) | Howmedica, Inc. | 1997-02-13 |
| REFLECTION ACETABULAR REINFORCEMENT RINGS (K962541) | Smith & Nephew Richards, Inc. | 1996-09-17 |
| PROTRUSION CAGES (K962007) | Depuy, Inc. | 1996-08-01 |
| OSTEONICS MICROSTRUCTURED ACETABULAR COMPONENTS (K925883) | Osteonics Corp. | 1993-06-15 |
| INTERMEDICS APR(TM) II FEMORAL COMPONENT (K890450) | Intermedics Orthopedics | 1989-08-09 |
Recalls involving this device
No recalls on record reference this clearance.