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..

1333
Total
1333
Cleared
115d
Avg days
1976
Since
1333 devices
505–528 of 1333
Cleared Jun 10, 2016
NEOVIEW Plating System
K160995
In2bones Sas
Orthopedic · 63d
Cleared May 26, 2016
AxSOS 3Ti
K153379
Stryker GmbH
Orthopedic · 185d
Cleared May 19, 2016
OsteoMed ExtremiLOCK Wrist Plating System
K161041
Osteomed
Orthopedic · 36d
Cleared May 17, 2016
BIOFOAM Bone Wedge
K152062
Wrightmedicaltechnologyinc
Orthopedic · 298d
Cleared May 17, 2016
GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System.
K153716
Gpc Medical, Ltd.
Orthopedic · 145d
Cleared Apr 22, 2016
Gridlock Ankle Plating System
K160177
Trilliant Surgical, Ltd.
Orthopedic · 86d
Cleared Apr 22, 2016
MotoBand(TM) CP Implant System
K160300
Crossroads Extremity Systems, LLC
Orthopedic · 78d
Cleared Apr 22, 2016
G3(TM) Active Plate(R) Small Fragment System
K160633
Genesis Fracture Care, Inc.
Orthopedic · 46d
Cleared Apr 06, 2016
KLS Martin Thoracic Plating System
K153482
KLS-Martin L.P.
Orthopedic · 125d
Cleared Mar 25, 2016
Align Anterior Ankle Fusion Plate
K160191
Extremity Medical, LLC
Orthopedic · 58d
Cleared Mar 24, 2016
Biomet Microfixation RibFix Blu Thoracic Fixation System
K152253
Biomet Microfixation
Orthopedic · 227d
Cleared Mar 09, 2016
Piccolo Composite(R) Distal Volar Radius Plate System
K160002
CarboFix Orthopedics , Ltd.
Orthopedic · 65d
Cleared Feb 25, 2016
IRENE Locking Compression Plate System
K151508
Tianjin Zhengtian Medical Instrument Co., Ltd.
Orthopedic · 266d
Cleared Feb 09, 2016
Epic Extremity Plate System
K153340
Epic Extremity, LLC
Orthopedic · 82d
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 Jan 07, 2016
Treace Medical Concepts (TMC) Plating System
K153531
Treace Medical Concepts, Inc.
Orthopedic · 29d
Cleared Dec 21, 2015
OsteoMed ExtremiLOCK Wrist Plating System
K152145
Osteomed
Orthopedic · 140d
Cleared Dec 21, 2015
AXI+LINE Proximal Bunion Correction System
K152548
Nextremity Solutions, Inc.
Orthopedic · 104d
Cleared Dec 11, 2015
MotoBand¿ CP Implant System
K152306
Crossroads Extremity Systems, LLC
Orthopedic · 119d
Cleared Dec 11, 2015
ORTHOLOC® 3Di Foot Plating Reconstruction System
K152974
Wrightmedicaltechnologyinc
Orthopedic · 64d
Cleared Dec 10, 2015
AOS Small Fragment Plating System
K152732
Avanced Orthopaedic Solutions, Inc. (Aos)
Orthopedic · 79d