SURGICAL SIMPLEX P BONE CEMENT
FDA premarket approval N17004/S013 · decided 2000-12-15
Approval details
- PMA number
- N17004
- Supplement
- S013
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SURGICAL SIMPLEX P BONE CEMENT
- Generic name
- BONE CEMENT
- Applicant
- Howmedica Corp.
- Date received
- 2000-12-01
- Decision date
- 2000-12-15
- Days to decision
- 14 days
- Decision code
- APPR
- Product code
- LOD
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Rutherford, NJ
- Statement
- APPROVAL FOR REMOVAL OF THE REDUNDANT CHEMICAL NAME LOCATED DIRECTLY BELOW THE BRAND NAME.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| MICRO DYNAMIC MESH (K983528) | Howmedica Corp. | 1998-12-23 |
| TYPE 3 FEMORAL COMPONENTS (K983404) | Howmedica Corp. | 1998-12-22 |
| DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATION (K980926) | Howmedica Corp. | 1998-12-16 |
| DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATION (K980925) | Howmedica Corp. | 1998-12-16 |
| DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATION (K980632) | Howmedica Corp. | 1998-12-11 |
| DURATION II ACETABULAR COMPONENTS-GAS PLASMA STERILIZATION (K980626) | Howmedica Corp. | 1998-12-11 |
| HOFFMANN II MIAMI POST (K983419) | Howmedica Corp. | 1998-11-25 |
| ZETA MULTIZONE LOCKING NAIL SYSTEM (K982958) | Howmedica Corp. | 1998-11-20 |