FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Impact PEEK Union Nail System
K Number: K252657
·
Decision Sep 19, 2025
Classifications
1
FEI Numbers
283
Registration Numbers
283
Same Product Code
203
Applicant Total
24
Review Days
28
Basic Information
- Device Name
- Impact PEEK Union Nail System
- K Number
- K252657
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nvision Biomedical Technologies, Inc.
- Date Received
- August 22, 2025
- Decision Date
- September 19, 2025
- Product Code
- HTY
- 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 |
|---|---|---|---|
| HTY | Pin, Fixation, Smooth | FDA class 2 | Orthopedic |
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