510(k) K210408

DePuy Synthes Variable Angle Locking Patella Plating System by Synthes (USA) Products, LLC — Product Code HRS

K210408 is an FDA 510(k) premarket notification submitted by Synthes (USA) Products, LLC for the device "DePuy Synthes Variable Angle Locking Patella Plating System". The FDA issued a decision of Substantially Equivalent on April 8, 2021. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Synthes (USA) Products, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 2021
Date Received
February 11, 2021
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