FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm
K Number: K201346
·
Decision Sep 23, 2020
Classifications
1
FEI Numbers
302
Registration Numbers
302
Same Product Code
528
Applicant Total
45
Review Days
125
Basic Information
- Device Name
- DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm
- K Number
- K201346
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3020
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Synthes (USA) Products, LLC
- Date Received
- May 21, 2020
- Decision Date
- September 23, 2020
- Product Code
- HSB
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HSB | Rod, Fixation, Intramedullary And Accessories | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
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