Cleared Traditional

DePuy Synthes 2.7mm VA LCP Clavicle Plate System

K201321 · DePuy Synthes · Orthopedic
Jul 2020
Decision
67d
Days
Class 2
Risk

About This 510(k) Submission

K201321 is an FDA 510(k) clearance for the DePuy Synthes 2.7mm VA LCP Clavicle Plate System, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by DePuy Synthes (19380, US). The FDA issued a Cleared decision on July 24, 2020, 67 days after receiving the submission on May 18, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K201321 FDA.gov
FDA Decision Cleared SESE
Date Received May 18, 2020
Decision Date July 24, 2020
Days to Decision 67 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HRS — Plate, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030

Similar Devices — HRS Plate, Fixation, Bone

All 1291
Xpert Hand
K253906 · Newclip Technics · Mar 2026
DePuy Synthes VOLT? Proximal Tibia 3.5 Plating System
K260069 · Synthes GmbH · Mar 2026
Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button
K260353 · Arthrex, Inc. · Mar 2026
VOLT? Ankle Trauma 2.7/3.5 Plating System; VOLT? Calcaneus 2.7 Plating System
K254054 · Synthes GmbH · Mar 2026
HKT Anatomical Locking Trauma System
K254249 · Hankil Tech Medical Co., Ltd. · Feb 2026
RIB LINK? Fixation System
K252166 · Globus Medical, Inc. · Feb 2026