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
361–384 of 1311
Cleared Dec 26, 2018
DePuy Synthes Trauma Orthopedic Nail Implants
K182783
DePuy Synthes
Orthopedic · 86d
Cleared Dec 21, 2018
TruMatch Graft Cage - Long Bone
K180821
Synthes (Usa), LLC
Orthopedic · 266d
Cleared Dec 10, 2018
Distal Radius Plating System
K182810
Miami Device Solutions, LLC
Orthopedic · 68d
Cleared Nov 20, 2018
ARIX Sternal System
K181806
Jeil Medical Corporation
Orthopedic · 137d
Cleared Nov 16, 2018
AdvantageRib Anterior System
K182179
Sig Medical Corp.
Orthopedic · 95d
Cleared Nov 16, 2018
Stratum™ Foot Plating System
K182201
Nextremity Solutions, Inc.
Orthopedic · 94d
Cleared Nov 01, 2018
DePuy Synthes Trauma Orthopedic Plates and Screws
K180310
Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.
Orthopedic · 269d
Cleared Nov 01, 2018
Medline Unite Mini Plates and Screws
K181820
Medline Industries, Inc.
Orthopedic · 115d
Cleared Oct 30, 2018
AOS Calcaneal Plating System
K182466
Advanced Orthopaedic Solutions
Orthopedic · 50d
Cleared Oct 22, 2018
ANTHEM Fracture System
K180554
Globus Medical, Inc.
Orthopedic · 235d
Cleared Oct 19, 2018
Titanium TomoFix Medial High Tibia Plate Anatomical
K180213
Synthes USA Products, LLC
Orthopedic · 267d
Cleared Oct 11, 2018
AxSOS 3 Ti
K181091
Stryker GmbH
Orthopedic · 170d
Cleared Oct 11, 2018
Piccolo Composite® Plate System
K182015
CarboFix Orthopedics , Ltd.
Orthopedic · 76d
Cleared Oct 10, 2018
Geminus Volar Distal Radius Plate System
K182492
Skeletal Dynamics, LLC
Orthopedic · 29d
Cleared Oct 05, 2018
ORTHOLOC SPS Shoulder Plating System
K181587
Tornier, Inc.
Orthopedic · 112d
Cleared Oct 04, 2018
WishBone Medical Plate and Screw System
K180736
Wishbone Medical, Inc.
Orthopedic · 196d
Cleared Oct 03, 2018
ARIX Clavicle System
K180972
Jeil Medical Corporation
Orthopedic · 173d
Cleared Sep 27, 2018
CoLink View Plating System
K182402
In2bones USA, LLC
Orthopedic · 23d
Cleared Sep 18, 2018
Tandry Locking Plate System
K171904
Microware Precision Co., Ltd.
Orthopedic · 449d
Cleared Aug 24, 2018
APTUS CMC-I Fusion Plate System
K181009
Medartis AG
Orthopedic · 129d
Cleared Aug 24, 2018
AOS Small Fragment Plating System Lite
K181035
Advanced Orthopaedic Solutions, Inc. (Aos)
Orthopedic · 128d
Cleared Aug 09, 2018
EVOS Wrist Fracture Plating System
K181533
Smith & Nephew, Inc.
Orthopedic · 59d
Cleared Aug 05, 2018
APTUS® Proximal Humerus System
K181425
Medartis AG
Orthopedic · 66d
Cleared Aug 02, 2018
PL8 Wrist Reconstruction Plate
K180150
Citieffe S.R.L.
Orthopedic · 195d