FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
Nexis osteosynthesis snap-off screws
K Number: K143146
·
Decision Feb 6, 2015
Classifications
1
FEI Numbers
659
Registration Numbers
659
Same Product Code
1058
Applicant Total
8
Review Days
95
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Basic Information
- Device Name
- Nexis osteosynthesis snap-off screws
- K Number
- K143146
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Novastep
- Date Received
- November 3, 2014
- Decision Date
- February 6, 2015
- Product Code
- HWC
- 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 |
|---|---|---|---|
| HWC | Screw, Fixation, Bone | FDA class 2 | Orthopedic |
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Other Clearances by Novastep
| K Number | Device Name | ||
|---|---|---|---|
| K230724 | arcad® 2.0 Duo & Quadro osteosynthesis compressive staples | Dec 4, 2023 | Substantially Equivalent |
| K223468 | Nexis® compressive screws | Aug 30, 2023 | Substantially Equivalent |
| K192356 | Airlock Centrolock Osteosynthesis Implant System | Dec 14, 2019 | Substantially Equivalent |
| K151277 | Airlock® osteosynthesis plate system | Aug 13, 2015 | Substantially Equivalent |
| K143523 | Airlock osteosynthesis plate system | Apr 6, 2015 | Substantially Equivalent |
| K143049 | LYNC intramedullary implant | Feb 19, 2015 | Substantially Equivalent |
| K143229 | Nexis osteosynthesis compressive screws | Feb 6, 2015 | Substantially Equivalent |