PALACOS R BONE CEMENT
FDA premarket approval P810020/S002 · decided 1989-01-30
Approval details
- PMA number
- P810020
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PALACOS R BONE CEMENT
- Generic name
- BONE CEMENT
- Applicant
- Smith & Nephew Richards, Inc.
- Date received
- 1988-12-12
- Decision date
- 1989-01-30
- Days to decision
- 49 days
- Decision code
- APPR
- Product code
- LOD
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| EMPOWER ANTERIOR DIRECT SCREWS (K965224) | Smith & Nephew Richards, Inc. | 1997-05-08 |
| GLOBAL TAPER TAPERED HIP SYSTEM, GT SPECTRON (K963509) | Smith & Nephew Richards, Inc. | 1997-01-27 |
| FINN ROD TO ROD CONNECTOR (K960444) | Smith & Nephew Richards, Inc. | 1997-01-24 |
| TRIMAX NAIL SYSTEM (K964163) | Smith & Nephew Richards, Inc. | 1996-12-27 |
| GENESIS II ZIRCONIUM FEMORAL COMPONENT/PROFIX ZIRCONIUM FEMORAL COMPONENT (K962557) | Smith & Nephew Richards, Inc. | 1996-12-05 |
| REVISION HIP SYSTEM (K963486) | Smith & Nephew Richards, Inc. | 1996-11-27 |
| REFLECTION ACETABULAR REINFORCEMENT RINGS (K962541) | Smith & Nephew Richards, Inc. | 1996-09-17 |
| ILIZAROV EXTERNAL FIXATION SYSTEM (K962808) | Smith & Nephew Richards, Inc. | 1996-08-19 |