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
481–504 of 1333
Cleared Dec 09, 2016
Medline UNITE® Ankle Fracture Plating System
K162829
Medline Industries, Inc.
Orthopedic · 63d
Cleared Dec 09, 2016
Biomet Microfixation RibFix Blu Thoracic Fixation System
K162974
Biomet Microfixation
Orthopedic · 45d
Cleared Nov 23, 2016
aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5
K161696
Aap Implantate AG
Orthopedic · 156d
Cleared Nov 23, 2016
Biomet Microfixation SternaLock 360 Sternal Closure System
K163007
Biomet Microfixation
Orthopedic · 26d
Cleared Nov 22, 2016
LOQTEQ® VA Distal Tibia Plate System: LOQTEQ® VA Distal Medial Tibia Plate 3.5
K161747
Aap Implantate AG
Orthopedic · 151d
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 04, 2016
AOS Small Fragment Plating System
K161913
Advanced Orthopaedic Solutions, Inc. (Aos)
Orthopedic · 115d
Cleared Nov 03, 2016
MatrixRIB Fixation System
K161590
Synthes USA Products, LLC
Orthopedic · 147d
Cleared Oct 31, 2016
Footmotion Plating System
K161448
Newclip Technics
Orthopedic · 159d
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