DURACON TOTAL KNEE SYSTEM TIBIAL COMPONENTS
FDA 510(k) clearance K915512 · decided 1992-08-18
Clearance details
- K-number
- K915512
- Device name
- DURACON TOTAL KNEE SYSTEM TIBIAL COMPONENTS
- Applicant
- Pfizer Hospital Products Group, Inc.
- Decision
- Substantially Equivalent for Some Indications
- Date received
- 1991-12-09
- Decision date
- 1992-08-18
- Days to decision
- 253 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 |
|---|---|---|
| DURATION A-P LIPPED TIB.INSERT-DURAC Intended for knee replacement Product Number: 6642-1- recall (Z-0916-2024) | Howmedica Osteonics Corp. | 2024-01-31 |
| DURATION A-P LIPPED TIB.INSERT-DURAC Intended for knee replacement Product Number: 6642-1- recall (Z-0917-2024) | Howmedica Osteonics Corp. | 2024-01-31 |
| DURATION PLASTIC PATELLA-DURACON Intended for knee replacement Product Number: 6642-2-200 recall (Z-0918-2024) | Howmedica Osteonics Corp. | 2024-01-31 |
| Duracon Total Knee, A-P Lipped Tibial Insert; 11MM Sterile; Howmedica Osteonics Corp. Stry recall (Z-1601-2009) | Stryker Howmedica Osteonics Corp. | 2009-07-07 |