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
745–768 of 1322
Cleared Mar 21, 2012
SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM
K120070
Synthes (Usa)
Orthopedic · 72d
Cleared Mar 12, 2012
ADAPTIVE WEDGE
K110662
Adaptive Specialty, LLC
Orthopedic · 370d
Cleared Mar 12, 2012
TRAUMA INTERNAL FIXATION SYSTEMS
K111663
DePuy Orthopaedics, Inc.
Orthopedic · 272d
Cleared Mar 12, 2012
ENHATCH ORTHOPAEDICS PATIENT/TECHNIQUE-SPECIFIC HUMERAL
K112663
Enhatch Orthopaedics, LLC
Orthopedic · 181d
Cleared Feb 29, 2012
2.7MM LCP ULNA OSTEOTOMY SYSTEM
K113364
Synthes USA Products, LLC
Orthopedic · 106d
Cleared Feb 17, 2012
ACUTE INNOVATIONS BIOBRIDGE RESORBABLE PLATING SYSTEM
K120163
Acute Innovations, LLC
Orthopedic · 29d
Cleared Feb 07, 2012
ORTHO SOLUTIONS EXTREMITY FIXATION IMPLANTS FOR OSTEOSYSNTHESIS
K111678
Ortho Solutions Limited
Orthopedic · 237d
Cleared Feb 06, 2012
CHECKMATE METATARSO-PHALANGEAL (MTP) ARTHRODESIS SYSTEM
K113762
Arthrosurface, Inc.
Orthopedic · 47d
Cleared Jan 31, 2012
CLAW II POLYAXIAL COMPRESSION SYSTEM AND ORTHOLOC 3DSI LOCKING SCREWS
K113014
Wrightmedicaltechnologyinc
Orthopedic · 112d
Cleared Jan 30, 2012
MAXLOCK EXTREME SYSTEM
K113048
Orthohelix Surgical Designs, Inc.
Orthopedic · 110d
Cleared Jan 27, 2012
NCB STRAIGHT NARROW SHAFT PLATES
K113718
Zimmer GmbH
Orthopedic · 39d
Cleared Jan 12, 2012
ACUTE INNOVATIONS MODULAR RIBLOC SYSTEM
K113318
Acute Innovations, LLC
Orthopedic · 63d
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