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
769–792 of 1333
Cleared Jan 11, 2012
SUSPENSION CLAVICLE FRACTURE REPAIR SYSTEM
K113405
Suspension Orthopaedic Solutions, LLC
Orthopedic · 54d
Cleared Jan 06, 2012
APTUS WRIST ARTHRODESIS PLATES
K112169
Medartis AG
Orthopedic · 162d
Cleared Dec 27, 2011
SUSPENSION CLAVICLE FRACTURE FIXATION SYSTEM
K112923
Suspension Orthopaedic Solutions, LLC
Orthopedic · 85d
Cleared Dec 23, 2011
STRYKER RESORBABLE FIXATION SYSTEM
K113109
Stryker
Orthopedic · 64d
Cleared Dec 19, 2011
AXSOS LOCKING PLATE SYSTEM
K112926
Stryker Corp.
Orthopedic · 77d
Cleared Dec 16, 2011
RECONSTRUCTION LOCKING PLATE AND 3.5MM LOCKING SCREW
K112819
Xiamen Double Engline Medical Material Co., Ltd.
Orthopedic · 79d
Cleared Dec 15, 2011
APTUS(R) DISTAL HUMERUS SYSTEM
K112560
Medartis AG
Orthopedic · 104d
Cleared Dec 12, 2011
ORTHOLOC 3DSI LOCKING SCREWS
K113339
Wrightmedicaltechnologyinc
Orthopedic · 28d
Cleared Dec 06, 2011
ASCENSION ATLAS HUMERAL PLATING SYSTEM
K110700
Ascension Orthopedics, Inc.
Orthopedic · 267d
Cleared Nov 17, 2011
SYNTHES LCP PEDIATRIC PLATE SYSTEMS
K112085
Synthes USA Products, LLC
Orthopedic · 119d
Cleared Nov 14, 2011
PERI-LOC PROXIMAL FEMUR LOCKING BONE PLATES
K112406
Smith & Nephew, Inc.
Orthopedic · 84d
Cleared Nov 04, 2011
TRIMED CLAVICLE FIXATION SYSTEM
K112509
TriMed, Inc.
Orthopedic · 66d
Cleared Oct 26, 2011
NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM
K112174
Zimmer, Inc.
Orthopedic · 90d
Cleared Oct 26, 2011
SYNTHES STERNAL FIXATION SYSTEM
K112689
Synthes, Inc.
Orthopedic · 41d
Cleared Oct 24, 2011
LATERAL SUPERIOR CLAVICLE PLATE, LEFT AND RIGHT
K103513
Advanced Orthopaedic Solutions, Inc.
Orthopedic · 328d
Cleared Oct 07, 2011
OSTEOMED HAND FUSION SYSTEM
K111419
Osteomed LP
Orthopedic · 140d
Cleared Oct 06, 2011
EASYLOCK OSTEOSYSTEM
K111266
TriMed, Inc.
Orthopedic · 155d
Cleared Sep 22, 2011
AIMING BLOCKS FOR VARIAX DISTAL RADIUS PLATES
K112455
Howmedica Osteonics Corp., Dba Stryker Orthopaedics
Orthopedic · 28d
Cleared Sep 09, 2011
IFS PROFILE PLATES, SCREWS, AND WASHERS
K110086
Internal Fixation Systems, Inc.
Orthopedic · 240d
Cleared Aug 23, 2011
SKELETAL DYNAMICS GEMINUS VOLAR DISTAL RADIUS PLATE MODEL STANDARD 3 HOLE RIGHT, STANDARD 3 HOLE LEFT, SKELETAL DYNAMICS
K111620
Skeletal Dynamics, LLC
Orthopedic · 74d
Cleared Aug 19, 2011
TRIMED RADIOCARPAL FUSION SYSTEM
K102785
TriMed, Inc.
Orthopedic · 326d
Cleared Aug 19, 2011
EVOLVE (R) TRIAD (TM) PLATING SYSTEM AND EVOLVE (R) TRIAD (TM) BONE SCREWS
K111432
Wrightmedicaltechnologyinc
Orthopedic · 88d
Cleared Aug 08, 2011
SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM
K111540
Synthes (Usa)
Orthopedic · 67d
Cleared Aug 05, 2011
ORTHOPEDIATRICS BLADE PLATE SYSTEM
K110959
OrthoPediatrics Corp.
Orthopedic · 122d