REFLECTION ACETABULAR REINFORCEMENT RINGS
FDA 510(k) clearance K962541 · decided 1996-09-17
Clearance details
- K-number
- K962541
- Device name
- REFLECTION ACETABULAR REINFORCEMENT RINGS
- Applicant
- Smith & Nephew Richards, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-06-28
- Decision date
- 1996-09-17
- Days to decision
- 81 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
- Memphis, TN, 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 |
| 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.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| OSTEOPAL (P810020/S005) | Smith & Nephew Richards, Inc. | 1998-10-15 |
| PALACOS E-FLOW (OSTEOPAL) BONE CEMENT (P810020/S004) | Smith & Nephew Richards, Inc. | 1998-07-30 |
| PALACOS R BONE CEMENT (P810020/S003) | Smith & Nephew Richards, Inc. | 1992-02-14 |
| PALACOS R BONE CEMENT (P810020/S002) | Smith & Nephew Richards, Inc. | 1989-01-30 |
| PALACOS R BONE CEMENT (P810020/S001) | Smith & Nephew Richards, Inc. | 1984-08-14 |
| PALACOS R BONE CEMENT (P810020) | Smith & Nephew Richards, Inc. | 1984-02-02 |