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
817–840 of 1333
Cleared Dec 09, 2010
2.4MM VA-LCP DORSAL DISTAL RADIUS PLATES
K102694
Synthes (Usa)
Orthopedic · 80d
Cleared Dec 07, 2010
SUSPENSION CLAVICLE FRACTURE FIXATION SYSTEM
K102095
Suspension Orthopaedic Solutions, LLC
Orthopedic · 134d
Cleared Dec 07, 2010
THE VARIA FIBULA LOCKED PLATING SYSTEM LINE EXTENSION ADDITION OF STRAIGHT PLATES
K102282
Howmedica Osteonics Corp., Dba Stryker Orthopaedics
Orthopedic · 117d
Cleared Dec 02, 2010
EVOLVE EPS ORTHOLOC
K102352
Wrightmedicaltechnologyinc
Orthopedic · 105d
Cleared Nov 24, 2010
HTO PLATING SYSTEM
K102505
Aesculap Implant Systems, LLC
Orthopedic · 84d
Cleared Nov 23, 2010
ORTHOLOC 3DI ANKLE PLATING SYSTEM, ORTHOLOC BONE SCREW
K102429
Wrightmedicaltechnologyinc
Orthopedic · 90d
Cleared Nov 09, 2010
LOCKING COMPRESSION PLATE
K101400
Changzhou Orthmed Medical Instrument Co., Ltd.
Orthopedic · 175d
Cleared Oct 22, 2010
CLAVICLE LOCKING PLATE SYSTEM
K100944
Newclip Technics
Orthopedic · 199d
Cleared Oct 20, 2010
CONTOURS VSP III VOLAR PLATING SYSTEM
K101936
Orthofix, Inc.
Orthopedic · 100d
Cleared Oct 06, 2010
ACUMED WRIST ARTHRODESIS PLATE SYSTEM
K100123
Acumed, LLC
Orthopedic · 264d
Cleared Sep 30, 2010
MAXLOCK EXTREME EXTREMITY PLATING SYSTEM DISTAL RADIUS PLATES AND SCREWS
K102156
Orthohelix Surgical Designs, Inc.
Orthopedic · 62d
Cleared Sep 27, 2010
MINI MAXLOCK EXTREME PLATING SYSTEM
K101962
Orthohelix Surgical Designs, Inc.
Orthopedic · 76d
Cleared Sep 15, 2010
2.7/3.5MM VA-LCP ANTERIRO CLAVICLE PLATE SYSTEM
K101536
Synthes (Usa), LLC
Orthopedic · 104d
Cleared Aug 05, 2010
I.T.S. LRS LOCKING RECONSTRUCTION SYSTEM
K093868
I.T.S. Implantat-Technologie-Systeme GmbH
Orthopedic · 231d
Cleared Aug 03, 2010
SYNTHES 2.4 MM/2.7 MM VARIABLE ANGLE LCP FOREFOOT/MIDFOOT SYSTEM
K100776
Synthes (Usa)
Orthopedic · 138d
Cleared Aug 02, 2010
ASCENSION TOTAL PLATE SYSTEM
K100502
Ascension Orthopedics, Inc.
Orthopedic · 161d
Cleared Jul 23, 2010
CLOSED FUSION PLATE, MTP PLATE, TALUS PLATE, MODEL 824077021, 22
K101240
DePuy Orthopaedics, Inc.
Orthopedic · 80d
Cleared Jun 25, 2010
SYNTEC OSTEO-PLATE AND SCREW FIXATION
K092889
Syntec Scientific Corp.
Orthopedic · 277d
Cleared Jun 16, 2010
ASCENSION ANKLE FUSION PLATE SYSTEM
K100176
Ascension Orthopedics, Inc.
Orthopedic · 146d
Cleared Jun 15, 2010
MEDICAL PLATES, LATERAL PLATES, POSTERIOR LATERAL PLATES, OLECRANON PLATES MODEL 131218704-708
K101421
DePuy Orthopaedics, Inc.
Orthopedic · 26d
Cleared Jun 14, 2010
OTIS -C PLUS
K100604
Sciences ET Bio Materiaux (Sbm)
Orthopedic · 103d
Cleared May 21, 2010
BIOMET FORERUNNER LOCKING PLATE SYSTEM
K092528
Biomet Trauma (Aka Ebi, Lp)
Orthopedic · 276d
Cleared May 17, 2010
ORTHOPEDIATRICS PEDILOC TIBIA PLATE SYSTEM
K100240
OrthoPediatrics Corp.
Orthopedic · 110d
Cleared May 14, 2010
VARI AX DISTAL RADIUS LINE EXTENSIONS OF XXL PLATES
K100271
Howmedica Osteonics Corp.
Orthopedic · 105d