FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
Activ Fuse
K Number: K202307
·
Decision Nov 17, 2020
Classifications
1
FEI Numbers
505
Registration Numbers
505
Same Product Code
1254
Applicant Total
16
Review Days
95
Basic Information
- Device Name
- Activ Fuse
- K Number
- K202307
- 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
- August 14, 2020
- Decision Date
- November 17, 2020
- Product Code
- HRS
- 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 |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HRS), ordered by most recent decision date.
TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)
FDA 510(k)
FDA Class 2
·Orthopedic
Genostis Osteosynthesis System
FDA 510(k)
FDA Class 2
·Orthopedic
Equinoxe® Scapula Fracture System
FDA 510(k)
FDA Class 2
·Orthopedic
TriMed Ulnar Osteotomy System (Ulnar Osteotomy Compression Plate); TriMed Ulnar Osteotomy System (Hex Cortical Screw 3.2mm); TriMed Ulnar Osteotomy System (Locking Cortical Screw 3.2mm); TriMed Ulnar Osteotomy System (Lag Screw 3.2mm)
FDA 510(k)
FDA Class 2
·Orthopedic
LORRAINE 2.5/3.5mm Distal Humerus System
FDA 510(k)
FDA Class 2
·Orthopedic
Montblanc Plate System
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Newclip Technics
| K Number | Device Name | ||
|---|---|---|---|
| K250155 | Xpert Knee | Apr 23, 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 |
| K172485 | Footmotion HammerToe | Mar 2, 2018 | Substantially Equivalent |
| K173746 | Activmotion Range | Feb 27, 2018 | Substantially Equivalent |
| K173641 | Activ Ankle | Jan 16, 2018 | Substantially Equivalent |