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
409–432 of 1322
Cleared Jan 16, 2018
Activ Ankle
K173641
Newclip Technics
Orthopedic · 53d
Cleared Jan 08, 2018
EVOS Small Fragment Upper Extremity Plates
K173293
Smith & Nephew, Inc.
Orthopedic · 84d
Cleared Jan 04, 2018
Alians Elbow Locking Plating System
K171372
Newclip Technics
Orthopedic · 239d
Cleared Dec 21, 2017
Life Spine Foot and Ankle Plating System
K172973
Life Spine, Inc.
Orthopedic · 86d
Cleared Dec 20, 2017
Breakaway Screw System
K172886
Paragon 28
Orthopedic · 90d
Cleared Dec 15, 2017
AxSOS 3 Ti
K172350
Stryker GmbH
Orthopedic · 134d
Cleared Dec 08, 2017
MDS Plating System
K172786
Miami Device Solutions, LLC
Orthopedic · 84d
Cleared Dec 06, 2017
OrthoPediatrics Wrist Fusion Plate
K172425
Orthopediatrics, Inc.
Orthopedic · 118d
Cleared Dec 01, 2017
ARIX Humerus System
K172008
Jeil Medical Corporation
Orthopedic · 151d
Cleared Nov 28, 2017
Ankle Fusion Plating System
K173121
In2bones Sas
Orthopedic · 60d
Cleared Nov 27, 2017
CoLink View Plating System
K172300
In2bones USA, LLC
Orthopedic · 119d
Cleared Nov 16, 2017
Minimally Invasive Bunion Plating System
K172178
Trilliant Surgical, Ltd.
Orthopedic · 120d
Cleared Nov 13, 2017
ANTHEM Fracture System
K173166
Globus Medical, Inc.
Orthopedic · 45d
Cleared Nov 06, 2017
Omni Foot Plating System
K172260
Extremity Medical, LLC
Orthopedic · 102d
Cleared Nov 06, 2017
EPIC Extremity Fracture Plate System
K172441
Epic Extremity, LLC
Orthopedic · 87d
Cleared Oct 23, 2017
G3™ Active Plate® Miniature System
K171293
Genesis Fracture Care, Inc.
Orthopedic · 174d
Cleared Sep 21, 2017
ARIX Wrist System
K170705
Jeil Medical Corporation
Orthopedic · 197d
Cleared Sep 21, 2017
DARCO Locking Bone Plate System
K171852
Wrightmedicaltechnologyinc
Orthopedic · 92d
Cleared Sep 08, 2017
Footmotion Plating System
K171510
Newclip Technics
Orthopedic · 107d
Cleared Sep 08, 2017
APTUS(R) Wrist 2.5 System
K172170
Medartis AG
Orthopedic · 52d
Cleared Sep 01, 2017
Arthrex Mesh Plate System
K170547
Arthrex, Inc.
Orthopedic · 189d
Cleared Aug 24, 2017
OrthoPediatrics Titanium PediPlates® System
K171173
OrthoPediatrics Corp.
Orthopedic · 125d
Cleared Aug 23, 2017
EVOS Small Fragment Plating System
K172262
Smith & Nephew, Inc.
Orthopedic · 27d
Cleared Aug 17, 2017
ARIX Ankle Fibula Hook Plate System
K170979
Jeil Medical Corporation
Orthopedic · 136d