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
313–336 of 1322
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
Cleared Jan 10, 2020
MotoBAND CP Implant System
K193452
Crossroads Extemity Systems, LLC
Orthopedic · 28d
Cleared Jan 05, 2020
TriMed ASET Foot Plating System
K192696
TriMed, Inc.
Orthopedic · 101d
Cleared Dec 23, 2019
Mini and Micro Fragments Reconstruction System – GMReis
K182718
Gm Dos Reis Industria E Comerico Ltda.
Orthopedic · 451d
Cleared Dec 14, 2019
Airlock Centrolock Osteosynthesis Implant System
K192356
Novastep
Orthopedic · 107d
Cleared Dec 13, 2019
Avanti Distal Radius and Forearm System
K191118
Avanti Orthopaedics, Inc.
Orthopedic · 231d
Cleared Dec 09, 2019
Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand of DHS Plating System
K191793
Nebula Surgical Private Limited
Orthopedic · 159d
Cleared Dec 03, 2019
Exsomed Wrist Plating System
K192473
Exsomed Corporation
Orthopedic · 84d
Cleared Nov 22, 2019
VariAx Foot
K192675
Stryker GmbH
Orthopedic · 57d
Cleared Nov 21, 2019
Axis Plating System
K192592
Extremity Medical, LLC
Orthopedic · 62d
Cleared Nov 18, 2019
PolyLock Small Bone Plating System
K192323
Fusion Orthopedics, LLC
Orthopedic · 83d
Cleared Nov 15, 2019
TDM Plate and Screw Systems
K190391
Tdm Co., Ltd.
Orthopedic · 269d
Cleared Nov 12, 2019
ARIX Wrist System
K191972
Jeil Medical Corporation
Orthopedic · 111d
Cleared Nov 08, 2019
APTUS Wrist Arthrodesis Plates
K192297
Medartis AG
Orthopedic · 77d