HRS · Class II · 21 CFR 888.3030

FDA Product Code HRS: Plate, Fixation, Bone

FDA product code HRS covers bone fixation plates.

These implants stabilize fractures and osteotomies by bridging and compressing bone segments during healing. They are used across skeletal sites including the hand, wrist, foot, and ankle.

HRS devices are Class II medical devices, regulated under 21 CFR 888.3030 and reviewed by the FDA Orthopedic panel.

Leading manufacturers include Synthes (Usa), Wrightmedicaltechnologyinc and Arthrex, Inc..

1319
Total
1319
Cleared
116d
Avg days
1976
Since
1319 devices
433–456 of 1319
Cleared Nov 18, 2016
EVOS Small Fragment Plating System
K162078
Smith & Nephew, Inc.
Orthopedic · 114d
Cleared Nov 15, 2016
VLP Wrist Fracture System
K161665
Smith & Nephew, Inc.
Orthopedic · 152d
Cleared Nov 04, 2016
LOQTEQ Distal Fibula Plate 3.5, Cancellous Screw 4.0, Washer
K161703
Aap Implantate AG
Orthopedic · 137d
Cleared Nov 03, 2016
MatrixRIB Fixation System
K161590
Synthes USA Products, LLC
Orthopedic · 147d
Cleared Oct 12, 2016
Ulna Plating System
K162424
Biomet, Inc.
Orthopedic · 43d
Cleared Sep 27, 2016
OrthoPediatrics Locking Proximal Femur System Cortical Screws
K162307
OrthoPediatrics Corp.
Orthopedic · 41d
Cleared Sep 21, 2016
ARIX Hand System
K161746
Jeil Medical Corporation
Orthopedic · 89d
Cleared Aug 15, 2016
Tarsa-Link Stand-Alone Wedge Fixation System
K161037
Life Spine, Inc.
Orthopedic · 124d
Cleared Aug 02, 2016
ARIX Foot System
K161864
Jeil Medical Corporation
Orthopedic · 26d
Cleared May 26, 2016
AxSOS 3Ti
K153379
Stryker GmbH
Orthopedic · 185d
Cleared May 17, 2016
BIOFOAM Bone Wedge
K152062
Wrightmedicaltechnologyinc
Orthopedic · 298d
Cleared Apr 06, 2016
KLS Martin Thoracic Plating System
K153482
KLS-Martin L.P.
Orthopedic · 125d
Cleared Jan 29, 2016
TriMed Humeral Supracondylar Fixation System
K151735
TriMed, Inc.
Orthopedic · 217d
Cleared Jan 28, 2016
Cable-Ready Cable Grip System: Cable-Ready Bone Plate System
K151716
Zimmer, Inc.
Orthopedic · 217d
Cleared Jan 21, 2016
aap LOQTEQ VA Radius Set 2.5
K153034
Aap Implantate AG
Orthopedic · 94d
Cleared Jan 14, 2016
ARIX Wrist System
K151468
Jeil Medical Corporation
Orthopedic · 227d
Cleared Dec 11, 2015
ORTHOLOC® 3Di Foot Plating Reconstruction System
K152974
Wrightmedicaltechnologyinc
Orthopedic · 64d
Cleared Nov 12, 2015
VLP Mini-Mod Talus Plates
K152976
Smith & Nephew, Inc.
Orthopedic · 35d
Cleared Oct 30, 2015
Acumed Ankle and Small Fragment Base Set Update
K151886
Acumed, LLC
Orthopedic · 113d
Cleared Oct 27, 2015
Anchorage 2 CP System
K151769
Stryker GmbH
Orthopedic · 119d
Cleared Sep 04, 2015
TOTAL COMPRESSION PLATING (TCP) SYSTEM
K151442
Wrightmedicaltechnologyinc
Orthopedic · 98d
Cleared Aug 28, 2015
Arthrex Fracture Plates
K151732
Arthrex, Inc.
Orthopedic · 63d
Cleared Aug 06, 2015
Medline Foot Plates and Screws
K151235
Medline Industries, Inc.
Orthopedic · 87d
Cleared Aug 06, 2015
VariAx 2 One-Third Tubular Plating System
K151879
Stryker GmbH
Orthopedic · 28d