FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
Newclip Patient-matched instrumentation non sterile PSI
K Number: K250767
·
Decision Oct 1, 2025
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
26
Applicant Total
32
Review Days
202
Basic Information
- Device Name
- Newclip Patient-matched instrumentation non sterile PSI
- K Number
- K250767
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Newclip Technics
- Date Received
- March 13, 2025
- Decision Date
- October 1, 2025
- Product Code
- PBF
- 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 |
|---|---|---|---|
| PBF | Orthopaedic Surgical Planning And Instrument Guides | FDA class 2 | Orthopedic |
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Other Clearances by Newclip Technics
| K Number | Device Name | ||
|---|---|---|---|
| K261038 | Xpert PFP | May 29, 2026 | Substantially Equivalent |
| K253906 | Xpert Hand | Mar 11, 2026 | Substantially Equivalent |
| K250155 | Xpert Knee | Apr 23, 2025 | Substantially Equivalent |
| K243912 | Newclip Patient-matched instrumentation non sterile PSI | Feb 13, 2025 | Substantially Equivalent |
| K240415 | Newclip Patient-matched instrumentation non sterile PSI | Nov 7, 2024 | Substantially Equivalent |
| K241539 | Activmotion S | Jul 30, 2024 | Substantially Equivalent |
| K221615 | Newclip Patient-matched instrumentation non sterile PSI | Oct 25, 2023 | Substantially Equivalent |
| K221395 | Footmotion Plating System | Jul 1, 2022 | Substantially Equivalent |
| K202803 | Activmotion S DTO | Dec 16, 2021 | Substantially Equivalent |
| K213214 | Xpert Wrist | Nov 24, 2021 | Substantially Equivalent |