DURACON MODULAR FEMORAL COMPONENT AND FEMORAL SPAC
FDA 510(k) clearance K920034 · decided 1992-03-18
Clearance details
- K-number
- K920034
- Device name
- DURACON MODULAR FEMORAL COMPONENT AND FEMORAL SPAC
- Applicant
- Pfizer Hospital Products Group, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-01-06
- Decision date
- 1992-03-18
- Days to decision
- 72 days
- Clearance type
- Traditional
- Product code
- JWH
- Device class
- 2
- Regulation number
- 888.3560
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Rutherford, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Duracon Total Knee Distal Femoral Locking Screw for 5 mm Spacer; Product No. 6632-5-600. M recall (Z-0014-2011) | Stryker Howmedica Osteonics Corp. | 2010-10-06 |
| Duracon Total Knee Modular Femoral Component; Non-Porous Right Medium Assembly, Product No recall (Z-1241-2007) | Stryker Howmedica Osteonics Corp. | 2007-09-21 |