510(k) K262618
K262618 is an FDA 510(k) premarket notification submitted by Arthrex, Inc. for the device "Arthrex Spine Compression FT Screw". The FDA issued a decision of Substantially Equivalent on Sep 24, 2026. The device falls under product code MRW (System, Facet Screw Spinal Device), a Class U device. Arthrex, Inc. has 354 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 24, 2026
- Date Received
- Jul 28, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Facet Screw Spinal Device
- Device Class
- Class U
- Review Panel
- OR
- Submission Type
- 510(k)