PROTRUSION CAGES
FDA 510(k) clearance K962007 · decided 1996-08-01
Clearance details
- K-number
- K962007
- Device name
- PROTRUSION CAGES
- Applicant
- Depuy, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-05-22
- Decision date
- 1996-08-01
- Days to decision
- 71 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
- Dayton, OH, 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 |
| OSTEONICS RESTORATION ACETABULAR RING (K970957) | Osteonics Corp. | 1997-06-03 |
| EXETER MESH (K963940) | Howmedica, Inc. | 1997-02-13 |
| REFLECTION ACETABULAR REINFORCEMENT RINGS (K962541) | Smith & Nephew Richards, Inc. | 1996-09-17 |
| 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.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ATTUNE Revision Rotating Platform (RP) Knee System (P830055/S346) | Depuy, Inc. | 2025-12-18 |
| LCS Total Knee System (P830055/S355) | Depuy, Inc. | 2025-12-15 |
| LCS® Total Knee System (P830055/S354) | Depuy, Inc. | 2025-12-11 |
| LCS® Total Knee System (P830055/S353) | Depuy, Inc. | 2025-12-09 |
| LCS® Total Knee System (P830055/S352) | Depuy, Inc. | 2025-11-26 |
| LCS® Total Knee System (P830055/S350) | Depuy, Inc. | 2025-09-26 |
| LCS® Total Knee System (P830055/S349) | Depuy, Inc. | 2025-09-09 |
| LCS Total Knee System (P830055/S348) | Depuy, Inc. | 2025-08-29 |