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
241–264 of 1322
Cleared Nov 24, 2021
Xpert Wrist
K213214
Newclip Technics
Orthopedic · 56d
Cleared Nov 18, 2021
CoLink Vallux Plating System
K212487
In2bones USA, LLC
Orthopedic · 101d
Cleared Nov 18, 2021
Stratum® Ankle Fusion Plating System
K212640
Nextremity Solutions, Inc.
General Hospital · 90d
Cleared Oct 18, 2021
LOQTEQ Proximal Humerus Plate 3.5 System
K211582
Aap Implantate AG
Orthopedic · 150d
Cleared Oct 05, 2021
SALGINA 2.5mm Volar Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, TAMlNA 3.5mm Proximal Humerus System, TRIFT 3.5mm 1/3 Tubular System
K203002
Bonebridge AG
Orthopedic · 369d
Cleared Oct 01, 2021
Anthem Fracture System
K212433
Globus Medical, Inc.
Orthopedic · 58d
Cleared Sep 21, 2021
GEO Extremity and Ankle Plating System
K212334
Gramercy Extremity Orthopedics, LLC
Orthopedic · 56d
Cleared Aug 20, 2021
Omni Foot and Ankle Plating System
K212297
Extremity Medical, LLC
Orthopedic · 29d
Cleared Aug 13, 2021
Tyber Medical Anatomical Plating System
K203817
Tyber Medical, LLC
Orthopedic · 227d
Cleared Jul 30, 2021
Summit Patella Plating System
K203408
Endeavor Orthopaedics, LLC
Orthopedic · 253d
Cleared Jul 28, 2021
FINE Osteotomy
K211646
Bodycad Laboratories, Inc.
Orthopedic · 61d
Cleared Jul 27, 2021
Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot System,Integra CAPTURE Screw System & Integra Ti6 Internal Fixation System,Subtalar MBA System,MetaSurg Subtalar Implant,NewDeal BOLD Screw,NewDeal HALLU Lock Plate System,NewDeal HALLU Plates,QWIX Positioning Screw,SPIN Snap-Off Screw,NewDeal TIBIAXYS System
K210016
Integra LifeSciences Corporation
Orthopedic · 204d
Cleared Jul 16, 2021
Avanti Orthopaedics Ulnar Shortening System
K211592
Avanti Orthopaedics, Inc.
Orthopedic · 53d
Cleared Jul 15, 2021
Acumed Clavicle Hook Plating System
K210750
Acumed, LLC
Orthopedic · 125d
Cleared Jul 09, 2021
TRUEMED HAND, FOOT AND ANKLE PLATES SYSTEM
K200575
Truemed Group, LLC
Orthopedic · 491d
Cleared Jun 29, 2021
Smith & Nephew Plates and Screws
K210837
Smith & Nephew, Inc.
Orthopedic · 99d
Cleared Jun 23, 2021
Valkyrie Thoracic Fixation System
K211695
Jm Longyear Manufacturing, LLC D.B.A. Able Medical Devices
Orthopedic · 21d
Cleared Jun 02, 2021
DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment LCP System)
K211051
DePuy Synthes
Orthopedic · 55d
Cleared May 06, 2021
DRPx Locking Distal Radius Plate System
K202971
Orthopaedic Implant Company
Orthopedic · 218d
Cleared Apr 30, 2021
JACE Medical Thoracic Plating System
K210290
Jace Medical, LLC
Orthopedic · 87d
Cleared Apr 20, 2021
SOLE Medial Column Fusion Plate
K210157
Orthofix Srl
Orthopedic · 89d
Cleared Apr 13, 2021
Volition Plating System
K210658
Ortho Solutions UK , Ltd.
Orthopedic · 40d
Cleared Apr 08, 2021
DePuy Synthes Variable Angle Locking Patella Plating System
K210408
Synthes USA Products, LLC
Orthopedic · 56d
Cleared Mar 26, 2021
DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating System
K210205
Synthes USA Products, LLC
Orthopedic · 59d