CMW 1 RADIOPAQUE, CMW2 AND CMW3 BONE CEMENTS
FDA premarket approval N18466/S019 · decided 1995-11-20
Approval details
- PMA number
- N18466
- Supplement
- S019
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- CMW 1 RADIOPAQUE, CMW2 AND CMW3 BONE CEMENTS
- Generic name
- BONE CEMENT
- Applicant
- Depuy, Inc.
- Date received
- 1995-09-20
- Decision date
- 1995-11-20
- Days to decision
- 61 days
- Decision code
- APPR
- Product code
- LOD
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Warsaw, IN
- Statement
- APPROVAL FOR CMW 1 RADIOPAQUE, CMW2 AND CMW3 TO BE MARKETED UNDER WRIGHT MEDICAL AS:ORTHOSET 1, ORTHOSET 2, AND ORTHOSET 3 BONE CEMENT, RESPECTIVELY.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| PINNACLE CONSTRAINED ACETABULAR LINERS (K043058) | Depuy, Inc. | 2005-03-14 |
| LPS UPPER EXTREMITY (K042664) | Depuy, Inc. | 2004-12-08 |
| LPS (LIMB PRESERVATION SYSTEM) LOWER EXTREMITY DOVETAIL INTERCALARY (K041085) | Depuy, Inc. | 2004-07-22 |
| LPS (K033959) | Depuy, Inc. | 2004-07-01 |
| DURALOC OPTION ACETABULAR CUP SYSTEM, MODELS 1599-01-044 TO -066, 1599-11-044 TO -062 AND 1599-21-044 TO -062 (K040544) | Depuy, Inc. | 2004-05-28 |
| DELTA SHOULDER (K021478) | Depuy, Inc. | 2003-11-18 |
| DEPUY ACE UNIVERSAL AND TROCH ENTRY FEMORAL NAIL SYSTEMS (K033329) | Depuy, Inc. | 2003-11-14 |
| DEPUY SIGMA TIBIAL INSERTS AND CO-CR TIBIAL TRAYS (K032151) | Depuy, Inc. | 2003-09-26 |