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
505–528 of 1322
Cleared Mar 09, 2016
Piccolo Composite(R) Distal Volar Radius Plate System
K160002
CarboFix Orthopedics , Ltd.
Orthopedic · 65d
Cleared Feb 25, 2016
IRENE Locking Compression Plate System
K151508
Tianjin Zhengtian Medical Instrument Co., Ltd.
Orthopedic · 266d
Cleared Feb 09, 2016
Epic Extremity Plate System
K153340
Epic Extremity, LLC
Orthopedic · 82d
Cleared Jan 29, 2016
TriMed Humeral Supracondylar Fixation System
K151735
TriMed, Inc.
Orthopedic · 217d
Cleared Jan 28, 2016
Cable-Ready Cable Grip System: Cable-Ready Bone Plate System
K151716
Zimmer, Inc.
Orthopedic · 217d
Cleared Jan 21, 2016
aap LOQTEQ VA Radius Set 2.5
K153034
Aap Implantate AG
Orthopedic · 94d
Cleared Jan 14, 2016
ARIX Wrist System
K151468
Jeil Medical Corporation
Orthopedic · 227d
Cleared Jan 07, 2016
Treace Medical Concepts (TMC) Plating System
K153531
Treace Medical Concepts, Inc.
Orthopedic · 29d
Cleared Dec 21, 2015
OsteoMed ExtremiLOCK Wrist Plating System
K152145
Osteomed
Orthopedic · 140d
Cleared Dec 21, 2015
AXI+LINE Proximal Bunion Correction System
K152548
Nextremity Solutions, Inc.
Orthopedic · 104d
Cleared Dec 11, 2015
MotoBand¿ CP Implant System
K152306
Crossroads Extremity Systems, LLC
Orthopedic · 119d
Cleared Dec 11, 2015
ORTHOLOC® 3Di Foot Plating Reconstruction System
K152974
Wrightmedicaltechnologyinc
Orthopedic · 64d
Cleared Dec 10, 2015
AOS Small Fragment Plating System
K152732
Avanced Orthopaedic Solutions, Inc. (Aos)
Orthopedic · 79d
Cleared Nov 25, 2015
NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET Brand of DHS/DCS Plating System
K150561
Narang Medical Limited
Orthopedic · 264d
Cleared Nov 25, 2015
SMV Scientific Bone Plate and Screw System
K152000
Smv Scientific
Orthopedic · 128d
Cleared Nov 24, 2015
G3¿ Active Plate® Large Fragment System
K152242
Genesis Fracture Care, Inc.
Orthopedic · 106d
Cleared Nov 12, 2015
VLP Mini-Mod Talus Plates
K152976
Smith & Nephew, Inc.
Orthopedic · 35d
Cleared Nov 05, 2015
RECON system- Grubber Lapidus-, Platar Lapidus-, Tarsalis Plates and Screws
K152256
Normed Medizin-Technik GmbH
Orthopedic · 87d
Cleared Nov 03, 2015
SternaLock® 360 Sternal Closure System
K151019
Biomet Microfixation
Orthopedic · 201d
Cleared Oct 30, 2015
Acumed Ankle and Small Fragment Base Set Update
K151886
Acumed, LLC
Orthopedic · 113d
Cleared Oct 30, 2015
RECON system-V-TEK-IVP Plates and Screws
K152312
Normed Medizin-Technik GmbH
Orthopedic · 74d
Cleared Oct 27, 2015
Anchorage 2 CP System
K151769
Stryker GmbH
Orthopedic · 119d
Cleared Sep 16, 2015
RECON system - MPJ-Plates
K152142
Normed Medizin-Technik GmbH
Orthopedic · 44d
Cleared Sep 04, 2015
TOTAL COMPRESSION PLATING (TCP) SYSTEM
K151442
Wrightmedicaltechnologyinc
Orthopedic · 98d