510(k) K222267

Arthrex 2.4 mm Volar Distal Radius Plate System by Arthrex, Inc. — Product Code HRS

K222267 is an FDA 510(k) premarket notification submitted by Arthrex, Inc. for the device "Arthrex 2.4 mm Volar Distal Radius Plate System". The FDA issued a decision of Substantially Equivalent on Oct 3, 2022. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Arthrex, Inc. has 352 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Oct 3, 2022
Date Received
Jul 28, 2022
Clearance Type
Traditional
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)