MEDACTA TOTAL HIP PROSTHESIS SYSTEM - QUADRA H AND R FEMORAL STEMS
FDA 510(k) clearance K082792 · decided 2008-12-29
Clearance details
- K-number
- K082792
- Device name
- MEDACTA TOTAL HIP PROSTHESIS SYSTEM - QUADRA H AND R FEMORAL STEMS
- Applicant
- Medacta International S.A.
- Decision
- Substantially Equivalent
- Date received
- 2008-09-23
- Decision date
- 2008-12-29
- Days to decision
- 97 days
- Clearance type
- Special
- Product code
- JDI
- Device class
- 2
- Regulation number
- 888.3350
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Medacta Quadra Trial Broach size 0 part # 01.10.10.045, for use with the Medacta Total Hip recall (Z-0791-2013) | Medacta Usa Inc | 2013-02-07 |