510(k) K263602

Arthrex Plates, Screws and Pins, and Washers by Arthrex, Inc. — Product Code HRS

K263602 is an FDA 510(k) premarket notification submitted by Arthrex, Inc. for the device "Arthrex Plates, Screws and Pins, and Washers". The FDA issued a decision of Substantially Equivalent on Oct 29, 2026. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Arthrex, Inc. has 356 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Oct 29, 2026
Date Received
Sep 30, 2026
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Plate, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type
510(k)

Source: FDA 510(k) database entry for K263602. Report a data issue: hello@regdatalab.com.