FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DePuy Synthes Retrograde Femoral Nail Advanced System
K Number: K233696
·
Decision Aug 1, 2024
Classifications
1
FEI Numbers
302
Registration Numbers
302
Same Product Code
528
Applicant Total
19
Review Days
258
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Basic Information
- Device Name
- DePuy Synthes Retrograde Femoral Nail Advanced System
- K Number
- K233696
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3020
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- DePuy Synthes
- Date Received
- November 17, 2023
- Decision Date
- August 1, 2024
- 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
Other 510(k) clearances with the same product code (HSB), ordered by most recent decision date.
AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)
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|---|---|---|---|
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| K221809 | DePuy Synthes 3.5mm Intrapelvic Acetabular System | Sep 20, 2022 | Substantially Equivalent |
| K213563 | DePuy Synthes Radial Head Replacement System | Mar 18, 2022 | Substantially Equivalent |
| K211051 | DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment LCP System) | Jun 2, 2021 | Substantially Equivalent |
| K203414 | DePuy Synthes 2.7mm VA LCP Clavicle Plate System, DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System | Dec 16, 2020 | Substantially Equivalent |
| K201959 | DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System | Sep 11, 2020 | Substantially Equivalent |