510(k) K201959

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

K201959 is an FDA 510(k) premarket notification submitted by DePuy Synthes for the device "DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System". The FDA issued a decision of Substantially Equivalent on September 11, 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
September 11, 2020
Date Received
July 14, 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