510(k) K201321

DePuy Synthes 2.7mm VA LCP Clavicle Plate System by DePuy Synthes — Product Code HRS

K201321 is an FDA 510(k) premarket notification submitted by DePuy Synthes for the device "DePuy Synthes 2.7mm VA LCP Clavicle Plate System". The FDA issued a decision of Substantially Equivalent on July 24, 2020. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. DePuy Synthes has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 24, 2020
Date Received
May 18, 2020
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