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
289–312 of 1311
Cleared Jul 08, 2020
Arthrex DynaNite Compression Plate
K193345
Arthrex, Inc.
Orthopedic · 218d
Cleared Jul 06, 2020
Arthrex MaxForce MTP Compression Plates and Screws
K201235
Arthrex, Inc.
Orthopedic · 60d
Cleared Jun 25, 2020
Lever Action Plate System
K200834
Mcginley Orthpaedic Innovations, LLC
Orthopedic · 87d
Cleared Jun 05, 2020
AxSOS 3 AF System and AxSOS 3 Ti System
K200398
Stryker GmbH
Orthopedic · 108d
Cleared Jun 01, 2020
Skeletal Dynamics Forearm Plating System
K200538
Skeletal Dynamics, Inc.
Orthopedic · 90d
Cleared May 22, 2020
JPS JuniOrtho Plating System
K200246
Orthofix Srl
Orthopedic · 112d
Cleared May 14, 2020
Distal Humerus Plating System
K200367
Skeletal Dynamics, Inc.
Orthopedic · 90d
Cleared May 14, 2020
Skeletal Dynamics Midshaft Humerus Plating System
K200701
Skeletal Dynamics, Inc.
Orthopedic · 57d
Cleared May 08, 2020
Treace Medical Concepts (TMC) Plating System
K200961
Treace Medical Concepts, Inc.
Orthopedic · 28d
Cleared Apr 23, 2020
CoLink Cfx Plating System
K200762
In2bones USA, LLC
Orthopedic · 30d
Cleared Apr 09, 2020
ATLAS Plating System
K191867
MiRus, LLC
Orthopedic · 272d
Cleared Mar 26, 2020
APTUS® Ankle Trauma System 2.8/3.5
K193633
Medartis AG
Orthopedic · 90d
Cleared Mar 26, 2020
APTUS® Foot 2.8-3.5 System
K193639
Medartis AG
Orthopedic · 90d
Cleared Mar 26, 2020
GEO 1st MTP Joint Arthrodesis Plating System
K200108
Gramercy Extremity Orthopedics, LLC
Orthopedic · 69d
Cleared Mar 25, 2020
FINE Osteotomy around the knee
K193614
Bodycad Laboratories, Inc.
Orthopedic · 90d
Cleared Mar 23, 2020
Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws
K200043
Field Orthopaedics Pty, Ltd.
Orthopedic · 75d
Cleared Mar 19, 2020
Park's Pectus System
K191057
Tdm Co., Ltd.
Orthopedic · 332d
Cleared Mar 04, 2020
ARIX Ankle System
K193616
Jeil Medical Corporation
Orthopedic · 69d
Cleared Feb 27, 2020
Pitkar Locked Plating System
K192619
S.H.Pitkar Orthotools Pvt. , Ltd.
Orthopedic · 157d
Cleared Feb 16, 2020
APTUS® Forearm Shaft Plates and APTUS® Wrist 2.5 System
K193554
Medartis AG
Orthopedic · 58d
Cleared Feb 03, 2020
Comus Locking Plate systems
K190842
Jiangsu Trauhui Medical Instrument Co., Ltd.
Orthopedic · 308d
Cleared Jan 24, 2020
APTUS Clavicle System
K192984
Medartis AG
Orthopedic · 91d
Cleared Jan 20, 2020
Tyber Medical Anatomical Plating System
K193222
Tyber Medical, LLC
Orthopedic · 59d
Cleared Jan 17, 2020
CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System, CoLink View Plating System, CoLink Afx Plating System
K193543
In2bones USA, LLC
Orthopedic · 28d