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
577–600 of 1322
Cleared Oct 31, 2014
Sternal Closure System
K142484
Jace Medical, LLC
Orthopedic · 57d
Cleared Oct 22, 2014
Zimmer Periarticular Plating System
K142579
Zimmer, Inc.
Orthopedic · 37d
Cleared Sep 26, 2014
PRO-LINK WEDGE SYSTEM
K141905
Life Spine
Orthopedic · 73d
Cleared Sep 26, 2014
I.T.S. Hand Locking Plates System - HLS
K142418
I.T.S. GmbH
Orthopedic · 29d
Cleared Sep 15, 2014
Flower Upper Extremity Plating Set
K142306
Flower Orthopedics Corporation
Orthopedic · 27d
Cleared Aug 29, 2014
DEPUY SYNTHES TOMOFIX OSTEOTOMY SYSTEM
K141796
Synthes USA Products, LLC
Orthopedic · 57d
Cleared Aug 28, 2014
DISTAL ELBOW PLATING SYSTEM
K140892
Skeletal Dynamics, LLC
Orthopedic · 142d
Cleared Aug 28, 2014
REDUCE FRACTURE PLATING SYSTEM LINE EXTENSION
K142135
Icon Orthopedic Concepts, LLC Dba Edge Orthopaedic
Orthopedic · 24d
Cleared Aug 21, 2014
VALOR HINDFOOT FUSION NAIL SYSTEM
K142121
Wrightmedicaltechnologyinc
Orthopedic · 17d
Cleared Aug 15, 2014
ARTHREX ANKLE FUSION PLATING SYSTEM
K141735
Arthrex, Inc.
Orthopedic · 49d
Cleared Aug 14, 2014
ZIMMER PLATES AND SCREWS SYSTEM(ZPS)- NON-STERILE PLATES AND SCREWS
K140508
Zimmer, Inc.
Orthopedic · 167d
Cleared Aug 13, 2014
ZIMMER PLATES AND SCREWS (ZPS)-NON-STERILE PLATES
K141517
Zimmer, Inc.
Orthopedic · 65d
Cleared Aug 13, 2014
ZIMMER PERIARTICULAR LOCKING SYSTEM
K141734
Zimmer, Inc.
Orthopedic · 47d
Cleared Aug 07, 2014
MATRIXRIB ENDO THORACOSCOPIC RIB PLATING SYSTEM
K141241
Synthes USA Products, LLC
Orthopedic · 86d
Cleared Aug 07, 2014
AAP LOQTEC CLAVICLE PLATES 2.7/3.5
K141823
Aap Implantate AG
Orthopedic · 31d
Cleared Aug 07, 2014
VARIAX 2 SYSTEM
K141992
Stryker Trauma AG
Orthopedic · 16d
Cleared Jul 29, 2014
Kangli Locking Plate System
K133840
Suzhou Kangli Orthopaedics Instrument Co., Ltd.
Orthopedic · 223d
Cleared Jul 29, 2014
PEDILOC FRAGMENT SYSTEM
K140431
OrthoPediatrics Corp.
Orthopedic · 159d
Cleared Jul 24, 2014
LINOS MOH HAND PLATING SYSTEM
K141489
KLS-Martin L.P.
Orthopedic · 49d
Cleared Jul 23, 2014
ORTHO SOLUTIONS ULTOS PLATING SYSTEM
K141784
Ortho Solutions Limited
Orthopedic · 21d
Cleared Jul 22, 2014
VIEW PLATING SYSTEM,REDUCE FRACTURE PLATING SYSTEM,BONE SCREW
K140876
Icon Orthopedic Concepts, LLC Dba Edge Orthopaedic
Orthopedic · 106d
Cleared Jul 22, 2014
VARIAX ELBOW PLATING SYSTEM
K141677
Stryker Trauma AG
Orthopedic · 29d
Cleared Jul 18, 2014
VARIAX DISTAL RADIUS PLATING SYSTEM
K141430
Stryker Leibinger GmbH & Co KG
Orthopedic · 49d
Cleared Jul 11, 2014
MAXLOCK EXTREME ELBOW FRACTURE SYSTEM
K141301
Orthohelix Surgical Designs, Inc.
Orthopedic · 53d