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..

1333
Total
1333
Cleared
115d
Avg days
1976
Since
1333 devices
577–600 of 1333
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
Cleared Oct 31, 2014
Sternal Closure System
K142484
Jace Medical, LLC
Orthopedic · 57d
Cleared Oct 22, 2014
Zimmer Periarticular Plating System
K142579
Zimmer, Inc.
Orthopedic · 37d
Cleared Sep 26, 2014
PRO-LINK WEDGE SYSTEM
K141905
Life Spine
Orthopedic · 73d
Cleared Sep 26, 2014
I.T.S. Hand Locking Plates System - HLS
K142418
I.T.S. GmbH
Orthopedic · 29d
Cleared Sep 15, 2014
Flower Upper Extremity Plating Set
K142306
Flower Orthopedics Corporation
Orthopedic · 27d
Cleared Aug 29, 2014
DEPUY SYNTHES TOMOFIX OSTEOTOMY SYSTEM
K141796
Synthes USA Products, LLC
Orthopedic · 57d
Cleared Aug 28, 2014
DISTAL ELBOW PLATING SYSTEM
K140892
Skeletal Dynamics, LLC
Orthopedic · 142d
Cleared Aug 28, 2014
REDUCE FRACTURE PLATING SYSTEM LINE EXTENSION
K142135
Icon Orthopedic Concepts, LLC Dba Edge Orthopaedic
Orthopedic · 24d
Cleared Aug 21, 2014
VALOR HINDFOOT FUSION NAIL SYSTEM
K142121
Wrightmedicaltechnologyinc
Orthopedic · 17d
Cleared Aug 15, 2014
ARTHREX ANKLE FUSION PLATING SYSTEM
K141735
Arthrex, Inc.
Orthopedic · 49d
Cleared Aug 14, 2014
ZIMMER PLATES AND SCREWS SYSTEM(ZPS)- NON-STERILE PLATES AND SCREWS
K140508
Zimmer, Inc.
Orthopedic · 167d
Cleared Aug 13, 2014
ZIMMER PLATES AND SCREWS (ZPS)-NON-STERILE PLATES
K141517
Zimmer, Inc.
Orthopedic · 65d
Cleared Aug 13, 2014
ZIMMER PERIARTICULAR LOCKING SYSTEM
K141734
Zimmer, Inc.
Orthopedic · 47d