FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Arthrex Virtual Implant Positioning (VIP) System
K Number: K230904
·
Decision Jun 22, 2023
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
25
Applicant Total
348
Review Days
83
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Basic Information
- Device Name
- Arthrex Virtual Implant Positioning (VIP) System
- K Number
- K230904
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3660
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Arthrex, Inc.
- Date Received
- March 31, 2023
- Decision Date
- June 22, 2023
- Product Code
- QHE
- 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 |
|---|---|---|---|
| QHE | Shoulder Arthroplasty Implantation System | FDA class 2 | Orthopedic |
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| K Number | Device Name | ||
|---|---|---|---|
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| K260561 | Arthrex FiberTak Suture Anchor | Mar 20, 2026 | Substantially Equivalent |
| K260405 | FiberTape Button | Mar 9, 2026 | Substantially Equivalent |
| K252196 | Arthrex FibuLock Nail System | Mar 5, 2026 | Substantially Equivalent |
| K260353 | Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button | Mar 3, 2026 | Substantially Equivalent |
| K254229 | Arthrex Nano FiberTak Suture Anchor | Mar 2, 2026 | Substantially Equivalent |
| K253713 | Arthrex Variable Angle (VA) Proximal Tibia Plating System | Jan 21, 2026 | Substantially Equivalent |
| K252807 | Arthrex Anatomic Lapidus Plates and I-Beam Lapidus Plates | Jan 12, 2026 | Substantially Equivalent |