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..

1311
Total
1311
Cleared
116d
Avg days
1976
Since
1311 devices
337–360 of 1311
Cleared Aug 08, 2019
CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan Compression Staple System
K190385
In2bones USA, LLC
Orthopedic · 170d
Cleared Aug 06, 2019
OrthoPediatrics PediFoot Deformity Corrections System
K190992
OrthoPediatrics Corp.
Orthopedic · 113d
Cleared Aug 01, 2019
LOQTEQ VA Calcaneus Plate 3.5
K182818
Aap Implantate AG
Orthopedic · 302d
Cleared Jul 29, 2019
CoLink® Mini Plating System
K191535
In2bones USA, LLC
Orthopedic · 49d
Cleared Jul 23, 2019
DePuy Synthes Craniomaxillofacial Sternal Devices - MR Conditional
K190963
Synthes USA Products, LLC
Orthopedic · 102d
Cleared Jul 17, 2019
ORTHOLOC™ SPS Shoulder Plating System
K191711
Tornier, Inc.
Orthopedic · 21d
Cleared Jun 21, 2019
DePuy Synthes Plates and Screws Portfolio
K190750
DePuy Synthes
Orthopedic · 88d
Cleared Jun 19, 2019
LOQTEQ VA Foot Plates 2.5
K182785
Aap Implantate AG
Orthopedic · 261d
Cleared Jun 10, 2019
Arzzt Distal Radius and Ulna System
K182650
Truemed Group, LLC
Orthopedic · 259d
Cleared Jun 07, 2019
RIVAL View Plating Systems and Reduce Fracture Plating Systems
K190388
Orthofix Srl
Orthopedic · 108d
Cleared Jun 06, 2019
PROSTEP TBC Implant System
K183620
Wrightmedicaltechnologyinc
Orthopedic · 162d
Cleared May 14, 2019
ORTHOLOC™ 2 Lapidus with Rotation System
K190670
Wrightmedicaltechnologyinc
Orthopedic · 60d
Cleared May 03, 2019
MatrixRIB Fixation System
K190409
DePuy Synthes
Orthopedic · 71d
Cleared Apr 19, 2019
ATLAS Plating System
K190415
MiRus, LLC
Orthopedic · 57d
Cleared Apr 12, 2019
Baby Gorilla/Gorilla Plating System
K190365
Paragon 28, Inc.
Orthopedic · 56d
Cleared Apr 12, 2019
MIS Bunion Plating System
K190658
Crossroads Extremity Systems, LLC
Orthopedic · 29d
Cleared Mar 11, 2019
EVOS Small Fragment Upper Extremity Plates Line Additions
K190253
Smith & Nephew, Inc.
Orthopedic · 32d
Cleared Mar 05, 2019
Stryker SternalPlate System
K183172
Stryker
Orthopedic · 109d
Cleared Mar 04, 2019
MLP Special Locking Bone Plate System
K181843
Maxxion Medical, LLC / Baumer SA
Orthopedic · 236d
Cleared Feb 19, 2019
MIS Bunion System
K181872
Crossroads Extremity Systems, LLC
Orthopedic · 222d
Cleared Feb 14, 2019
AdvantageRib System
K183317
Sig Medical Corporation
Orthopedic · 76d
Cleared Feb 13, 2019
EPIC Extremity Fusion Plate System
K182991
Epic Extremity, LLC
Orthopedic · 107d
Cleared Jan 25, 2019
Treace Medical Concepts (TMC) Plating System
K183321
Treace Medical Concepts, Inc.
Orthopedic · 56d
Cleared Jan 10, 2019
Additive Orthopaedics Patient Specific 3D Locking Lattice Plates
K183011
Additive Orthopaedics
Orthopedic · 71d