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
721–744 of 1333
Cleared Nov 14, 2012
KLS MARTIN RECON TALON
K122860
KLS-Martin L.P.
Orthopedic · 57d
Cleared Nov 08, 2012
AAP LOQTEQ DISTAL MEDIAL TIBIA PLATE 3.5 SYSTEM
K113601
Aap Implantate AG
Orthopedic · 339d
Cleared Oct 31, 2012
AAP LOQTEQ PROXIMAL LATERAL TIBIA PLATE 4.5 SYSTEM
K113602
Aap Implantate AG
Orthopedic · 331d
Cleared Oct 12, 2012
ORTHOLOC 3DI MIDFOOT/FLATFOOT SYSTEM
K121651
Wrightmedicaltechnologyinc
Orthopedic · 129d
Cleared Oct 12, 2012
PIONEER STERNAL CABLE PLATE SYSTEM
K122293
Pioneer Surgical Technology, Inc.
Orthopedic · 73d
Cleared Oct 03, 2012
GEMINUS FOSSA SPECIFIC PLATE SYSTEM
K122737
Skeletal Dynamics, LLC
Orthopedic · 27d
Cleared Oct 01, 2012
ORTHOLOC 3DI ANKLE FUSION PLATING SYSTEM
K121425
Wrightmedicaltechnologyinc
Orthopedic · 140d
Cleared Oct 01, 2012
AFT PROXIMAL HUMERUS FRACTURE PLATE
K121672
Shoulder Options, Inc.
Orthopedic · 117d
Cleared Oct 01, 2012
AXSOS DISTAL LATERAL FEMUR TS LONG PLATES
K122308
Howmedica Osteonics Corp., Dba Stryker Orthopaedics
Orthopedic · 61d
Cleared Sep 26, 2012
SHORT LATERAL SUPERIOR CLAVICLE PLATE, LEFT AND RIGHT MODEL 3017-000 (LEFT) AND 3018-000 (RIGHT)
K122623
Advanced Orthopaedic Solutions, Inc.
Orthopedic · 29d
Cleared Sep 19, 2012
BIOMET MICROFIXATION STERNAL CLOSURE SYSTEM
K121302
Biomet Microfixation
Orthopedic · 141d
Cleared Sep 06, 2012
LOQTEQ LARGE FRAGMENT SET LOQTEQ CORTICAL SCREW 4.5, SMALL HEAD, T25, SELF TAPPING LOQTEQ CORTICAL SCREW 4.5, T25, SELF
K113648
Aap Implantate AG
Orthopedic · 269d
Cleared Sep 06, 2012
MAXLOCK EXTREME SYSTEM
K122005
Orthohelix Surgical Designs, Inc.
Orthopedic · 59d
Cleared Aug 30, 2012
LOQTEQ SMALL FRAGMENT SET LOQTEQ CORTICAL SCREW3.5, SMALL HEAD, T15, SELF TAPPING LOQTEQ CORTICAL SCREW 3.5, T15, SELF T
K113652
Aap Implantate AG
Orthopedic · 262d
Cleared Aug 20, 2012
GRIDLOCK PLATING SYSTEM
K121452
Trilliant Surgical, Ltd.
Orthopedic · 96d
Cleared Jul 26, 2012
PIONEER STERNAL ASSIST IMPLANT SYSTEM
K120016
Pioneer Surgical Technology, Inc.
Orthopedic · 205d
Cleared Jul 13, 2012
CONGRUENT BONE PLATE SYSTEM: ACU-LOC 2 PLATE
K120903
Acumed, LLC
Orthopedic · 109d
Cleared Jul 06, 2012
SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM-ANTEROLATERAL DISTAL TIBIA PLATE
K121601
Synthes (Usa)
Orthopedic · 35d
Cleared Jun 18, 2012
SYNTHES VA LCP ANKLE TRAUMA SYSTEM
K120854
Synthes (Usa)
Orthopedic · 89d
Cleared Jun 13, 2012
MINI MAXLOCK EXTREME PLATING SYSTEM
K121437
Orthohelix Surgical Designs, Inc.
Orthopedic · 29d
Cleared Jun 12, 2012
NCB PERIPROSTHETIC TROCHANTER PLATES AND SCREWS, NCB CABLE BUTTON FOR NCB OPLYAXIAL LOCKING PLATE
K120772
Zimmer GmbH
Orthopedic · 90d
Cleared Jun 04, 2012
SYNTHES 3.5 MM VA-LCP PROXIMAL TIBIA PLATE SYSTEM
K120689
Synthes USA Products, LLC
Orthopedic · 90d
Cleared May 29, 2012
ORTHO SOLUTIONS TRAUMA PLATES FOR OSTEOSYSNTHESIS
K120360
Ortho Solutions Limited
Orthopedic · 113d
Cleared May 10, 2012
EOS SMALL BONE FIXATION SYSTEM
K112794
TriMed, Inc.
Orthopedic · 227d