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..

1322
Total
1322
Cleared
116d
Avg days
1976
Since
1322 devices
481–504 of 1322
Cleared Oct 21, 2016
Distal Radius Plating System
K162635
Miami Device Solutions, LLC
Orthopedic · 30d
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 Sep 07, 2016
Additive Orthopaedics Bone Wedge System
K153207
Additive Orthopaedics, LLC
Orthopedic · 307d
Cleared Aug 17, 2016
Alians Elbow Locking Plating System
K152289
Newclip Technics
Orthopedic · 370d
Cleared Aug 15, 2016
Tarsa-Link Stand-Alone Wedge Fixation System
K161037
Life Spine, Inc.
Orthopedic · 124d
Cleared Aug 15, 2016
Distal Radius Plating System
K161292
Miami Device Solutions, LLC
Orthopedic · 98d
Cleared Aug 11, 2016
Converge
K153573
Biomedical Enterprises, Inc.
Orthopedic · 240d
Cleared Aug 02, 2016
ARIX Foot System
K161864
Jeil Medical Corporation
Orthopedic · 26d
Cleared Aug 02, 2016
Biomet Microfixation Sternal Closure System
K161896
Biomet Microfixation
Orthopedic · 22d
Cleared Jul 26, 2016
Conventus Orthopaedics Ulna Fixation System
K161048
Conventus Orthopaedics, Inc.
Orthopedic · 103d
Cleared Jun 17, 2016
CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of DHS/DCS Plating System
K153374
Orthocare
Orthopedic · 207d
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