DePuy Synthes TFNA Augmentation System
FDA 510(k) clearance K160167 · decided 2016-09-26
Clearance details
- K-number
- K160167
- Device name
- DePuy Synthes TFNA Augmentation System
- Applicant
- Synthes (USA) Products, LLC
- Decision
- Substantially Equivalent
- Date received
- 2016-01-27
- Decision date
- 2016-09-26
- Days to decision
- 243 days
- Clearance type
- Traditional
- Product code
- HSB
- Device class
- 2
- Regulation number
- 888.3020
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- West Chester, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| TFNA Femoral Nail 9mm, right, 130, L 235mm-Intended for temporary fixation and stabilizati recall (Z-1239-2024) | Synthes (USA) Products LLC | 2024-03-01 |
| TFNA Femoral Nail 11mm, right, 130, L 235mm-Intended for temporary fixation and stabilizat recall (Z-1240-2024) | Synthes (USA) Products LLC | 2024-03-01 |