FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Arthrex PushLock Suture Anchors
K Number: K251145
·
Decision Jul 10, 2025
Classifications
1
FEI Numbers
263
Registration Numbers
263
Same Product Code
564
Applicant Total
110
Review Days
87
Basic Information
- Device Name
- Arthrex PushLock Suture Anchors
- K Number
- K251145
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Arthrex Inc.
- Date Received
- April 14, 2025
- Decision Date
- July 10, 2025
- Product Code
- MBI
- 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 |
|---|---|---|---|
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | FDA class 2 | Orthopedic |
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Other Clearances by Arthrex Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K251453 | Arthrex iBalance Partial Knee System | Jul 1, 2025 | Substantially Equivalent |
| K243480 | SuturePatch Tissue Reinforcement | May 29, 2025 | Substantially Equivalent |
| K250596 | Arthrex FiberTak Suture Anchor | Mar 28, 2025 | Substantially Equivalent |
| K243995 | Arthrex Humeral Plating System and Cerclage Button | Mar 26, 2025 | Substantially Equivalent |
| K250424 | Arthrex TightRope Soft Button, RT | Mar 11, 2025 | Substantially Equivalent |
| K243344 | Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures | Feb 20, 2025 | Substantially Equivalent |
| K243742 | Arthrex DynaNite Nitinol Staples | Jan 31, 2025 | Substantially Equivalent |
| K243890 | Arthrex Intramedullary Nails | Jan 13, 2025 | Substantially Equivalent |
| K242079 | Arthrex Elbow Fracture Plating System | Nov 14, 2024 | Substantially Equivalent |
| K240815 | Arthrex Cannulated Screw System | Jun 13, 2024 | Substantially Equivalent |