510(k) K260624
K260624 is an FDA 510(k) premarket notification submitted by Arthrex, Inc. for the device "Arthrex Radial Head Replacement System". The FDA issued a decision of Substantially Equivalent on Jul 30, 2026. The device falls under product code KWI (Prosthesis, Elbow, Hemi-, Radial, Polymer), a Class II device regulated under 21 CFR 888.3170. Arthrex, Inc. has 354 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 30, 2026
- Date Received
- Feb 26, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Elbow, Hemi-, Radial, Polymer
- Device Class
- Class II
- Regulation Number
- 888.3170
- Review Panel
- OR
- Submission Type
- 510(k)