SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT
FDA premarket approval N17004/S008 · decided 1996-12-18
Approval details
- PMA number
- N17004
- Supplement
- S008
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT
- Generic name
- BONE CEMENT
- Applicant
- Howmedica Corp.
- Date received
- 1996-11-18
- Decision date
- 1996-12-18
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- LOD
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Rutherford, NJ
- Statement
- APPROVAL FOR MINOR CHANGES TO PACKAGING AND LABELING OF THE PRODUCT.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
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 |