SYMMETRIC TOTAL KNEE SYSTEM
FDA 510(k) clearance K080199 · decided 2008-07-03
Clearance details
- K-number
- K080199
- Device name
- SYMMETRIC TOTAL KNEE SYSTEM
- Applicant
- Signal Medical Corporation
- Decision
- Substantially Equivalent
- Date received
- 2008-01-25
- Decision date
- 2008-07-03
- Days to decision
- 160 days
- Clearance type
- Traditional
- Product code
- JWH
- Device class
- 2
- Regulation number
- 888.3560
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- St. Louis, MO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Symmetric Total Knee Femoral Components Product Usage: Symmetric Total Knee Femoral Compon recall (Z-0111-2015) | Signal Medical Corporation | 2014-10-22 |