510(k) K251620

A.L.P.S. Proximal Humerus Plating System by Zimmer Biomet — Product Code HRS

K251620 is an FDA 510(k) premarket notification submitted by Zimmer Biomet for the device "A.L.P.S. Proximal Humerus Plating System". The FDA issued a decision of Substantially Equivalent on July 25, 2025. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Zimmer Biomet has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 2025
Date Received
May 27, 2025
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