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
553–576 of 1322
Cleared Mar 30, 2015
Eminent Foot Plate System
K143365
Eminent Spine
Orthopedic · 126d
Cleared Mar 30, 2015
Biomet Proximal Humerus Plating System
K143697
Biomet Manufacturing
Orthopedic · 96d
Cleared Mar 24, 2015
Tarsa-Link Wedge Fixation System
K150368
Life Spine
Orthopedic · 40d
Cleared Mar 23, 2015
Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws)
K150099
Synthes USA Products, LLC
Orthopedic · 62d
Cleared Mar 20, 2015
PROXIMAL HUMERUS PLATING SYSTEM
K141493
Miami Device Solutions
Orthopedic · 288d
Cleared Mar 19, 2015
Treace Medical Concepts(TMC) Plating System
K143717
Treace Medical Concepts, Inc.
Orthopedic · 80d
Cleared Mar 04, 2015
Zimmer Plates and Screws System (ZPS) - Non-sterile ZPS
K143331
Zimmer, Inc.
Orthopedic · 104d
Cleared Mar 03, 2015
IDEAL Locking Plate System
K141825
Jiangsu Ideal Medical Science & Technology Co., LT
Orthopedic · 239d
Cleared Feb 25, 2015
Biomet Microfixation Thoracic Fixation System
K142823
Biomet Microfixation
Orthopedic · 148d
Cleared Feb 25, 2015
Baide
K150009
Jiangsu Baide Medical Intrument Co., Ltd.
Orthopedic · 54d
Cleared Feb 23, 2015
Zimmer Periarticular Plating System
K150121
Zimmer, Inc.
Orthopedic · 34d
Cleared Jan 30, 2015
HIGH TIBIAL OSTEOTOMY SYSTEM
K141548
Newclip Technics
Orthopedic · 233d
Cleared Jan 26, 2015
Activ Ankle Locking Plating System
K143061
Newclip Technics
Orthopedic · 94d
Cleared Jan 23, 2015
Acumed Small Fragment Base Set
K143394
Acumed, LLC
Orthopedic · 58d
Cleared Jan 16, 2015
Nitinol Compression Plating System
K143023
Biomedical Enterprises, Inc.
Orthopedic · 87d
Cleared Jan 16, 2015
Arthrex Fracture System
K143139
Arthrex, Inc.
Orthopedic · 74d
Cleared Dec 23, 2014
ALIANS ULNA LOCKING PLATING SYSTEM
K142502
Newclip Technics
Orthopedic · 109d
Cleared Dec 22, 2014
AxSOS 3 Ti Locking Plate System
K143138
Stryker Trauma AG
Orthopedic · 49d
Cleared Dec 18, 2014
VLP Mini-Mod Small Bone Plating System 1.5mm Plates and Screws
K143050
Smith & Nephew, Inc.
Orthopedic · 56d
Cleared Dec 16, 2014
Mini and Micro Fragments Reconstruction System-NEOFIX
K142419
Neoortho Productos Orthopedicos S/A
Orthopedic · 110d
Cleared Dec 05, 2014
TOTAL COMPRESSION PLATING SYSTEM
K143025
Wrightmedicaltechnologyinc
Orthopedic · 45d
Cleared Nov 28, 2014
Zimmer Plates and Screws (ZPS) - Non Sterile Plate Line Extensions, Sterile/Non-Sterile ZPS / Screws and Washers
K143066
Zimmer, Inc.
Orthopedic · 35d
Cleared Nov 26, 2014
G3 Active Plate Large Fragment System
K142938
Genesis Fracture Care, Inc.
Orthopedic · 48d
Cleared Nov 12, 2014
Zimmer Plates and Screws (ZPS), Forte Screws
K142836
Zimmer, Inc.
Orthopedic · 43d