DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm
FDA 510(k) clearance K201346 · decided 2020-09-23
Clearance details
- K-number
- K201346
- Device name
- DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm
- Applicant
- Synthes (USA) Products, LLC
- Decision
- Substantially Equivalent
- Date received
- 2020-05-21
- Decision date
- 2020-09-23
- Days to decision
- 125 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 |
|---|---|---|
| LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 46MM / XL25/ STER. Product Code: 04.045.346TS. recall (Z-0228-2026) | Synthes (USA) Products LLC | 2025-10-21 |
| LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 42MM / XL25/ STER. Product Code: 04.045.342TS. recall (Z-0229-2026) | Synthes (USA) Products LLC | 2025-10-21 |