510(k) K251690
K251690 is an FDA 510(k) premarket notification submitted by Arthrex, Inc. for the device "Arthrex SpeedFLEX Implant". The FDA issued a decision of Substantially Equivalent on September 30, 2025. The device falls under product code OWY (Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon), a Class II device regulated under 21 CFR 878.3300. Arthrex, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 30, 2025
- Date Received
- June 2, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon
- Device Class
- Class II
- Regulation Number
- 878.3300
- Review Panel
- OR
- Submission Type
For reinforcement of soft tissue where weakness exists in tendon repair.