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
601–624 of 1333
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
Cleared Jul 09, 2014
BIOFOAM BONE WEDGE
K140531
Wrightmedicaltechnologyinc
Orthopedic · 127d
Cleared Jul 09, 2014
CHARLOTTE (TM) MTP BONE FUSION PLATE SYSTEM HEX SCREW
K141417
Wrightmedicaltechnologyinc
Orthopedic · 41d
Cleared Jul 08, 2014
ARTHREX FRACTURE PLATES AND SCREWS
K141478
Arthrex, Inc.
Orthopedic · 34d
Cleared Jun 30, 2014
MBD PLATE SYSTEM
K141045
Mbd Medical, LLC
Orthopedic · 68d
Cleared Jun 23, 2014
APTUS ULNA SHORTENING 2.5
K141232
Medartis AG
Orthopedic · 41d
Cleared Jun 20, 2014
AXSOS 3 TI LOCKING PLATE SYSTEM
K141121
Stryker Trauma AG
Orthopedic · 51d
Cleared Jun 20, 2014
VARIAX 2 ONE THIRD TUBULAR PLATING SYSTEM
K141204
Stryker Trauma AG
Orthopedic · 42d
Cleared Jun 13, 2014
ACUMED HAND FRACTURE SYSTEM
K141383
Acumed, LLC
Orthopedic · 17d
Cleared Jun 09, 2014
OIC VARIABLE ANGLE SMALL FRAGMENT LOCKING PLATE SYSTEM
K140357
Orthopaedic Implant Company
Orthopedic · 117d
Cleared Jun 03, 2014
OTIS-C-PLUS, NEOTIS PLATE, SCREW 06.5
K140226
Science For Biomaterials
Orthopedic · 125d
Cleared May 29, 2014
VARIAX 2 COMPRESSION PLATING SYSTEM
K140565
Stryker Trauma AG
Orthopedic · 85d
Cleared May 22, 2014
SALVATION 3DI PLATING SYSTEM
K140792
Wrightmedicaltechnologyinc
Orthopedic · 52d
Cleared May 14, 2014
MSP METATARSAL SHORTENING SYSTEM
K140724
Nextremity Solutions, Inc.
Orthopedic · 54d