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
433–456 of 1322
Cleared Aug 14, 2017
ARIX Foot System (2.3/2.8)
K170780
Jeil Medical Corporation
Orthopedic · 152d
Cleared Aug 03, 2017
Arzzt 3.5 / 4.5 Small & Large Fragments System
K162507
Truemed Group, LLC
Orthopedic · 329d
Cleared Jul 27, 2017
ARIX Ankle Distal Tibia System
K170313
Jeil Medical Corporation
Orthopedic · 176d
Cleared Jul 24, 2017
ARIX Diaphysis System
K171285
Jeil Medical Corporation
Orthopedic · 84d
Cleared Jul 14, 2017
In2Bones Fracture and Correction System
K170518
In2bones USA, LLC
Orthopedic · 143d
Cleared Jun 30, 2017
DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist Fusion Plate (WFP) – MR Conditional, DePuy Synthes Large Fragment Dynamic Compression Locking (DCL) System –MR Conditional, DePuy Synthes Small Fragment Dynamic Compression Locking (DCL) System – MR Conditional, DePuy Synthes Modular Foot System – MR Conditional, DePuy Synthes T-Plates – MR Conditional, DePuy Synthes One-third Tubular Plate with Collar (OTPC) – MR Conditional, DePuy Synthes Stainless S
K160553
Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.
Orthopedic · 487d
Cleared Jun 27, 2017
Distal Elbow Plating System
K171590
Skeletal Dynamics, LLC
Orthopedic · 27d
Cleared Jun 22, 2017
VariAx 2 Compression Plating System
K170727
Stryker GmbH
Orthopedic · 105d
Cleared Jun 20, 2017
Additive Orthopaedics Bunion System
K163593
Additive Orthopaedics, LLC
Orthopedic · 181d
Cleared Jun 16, 2017
BioPro Foot Plating Systems
K162674
Biopro, Inc.
Orthopedic · 263d
Cleared Jun 16, 2017
Alians Fragment Specific
K170843
Newclip Technics
Orthopedic · 87d
Cleared Jun 14, 2017
EVOS Small Fragment Lower Extremity Plates
K170457
Smith & Nephew, Inc.
Orthopedic · 119d
Cleared May 12, 2017
Piccolo Composite® Plate System
K170401
CarboFix Orthopedics , Ltd.
Orthopedic · 92d
Cleared May 08, 2017
VariAx 2 Foot System
K170771
Stryker GmbH
Orthopedic · 55d
Cleared May 05, 2017
Colink™ Plating System
K163293
In2bones USA, LLC
Orthopedic · 164d
Cleared May 02, 2017
Locking Plate System
K162380
Beijing Keyi Medical Device Technology Co., Ltd.
Orthopedic · 251d
Cleared Apr 24, 2017
Pantheon Medical Balanced Plating System
K162154
Pantheon Medical
Orthopedic · 265d
Cleared Apr 24, 2017
ORTHOLOC® 3Di Ankle Fusion Plating System Line Extension
K163650
Wrightmedicaltechnologyinc
Orthopedic · 122d
Cleared Apr 24, 2017
EVOS Small Fragment Plating System
K170887
Smith & Nephew, Inc.
Orthopedic · 28d
Cleared Apr 19, 2017
GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND Of DHS/Dynamic Condylar Plate Plating System
K163383
Greens Surgicals Pvt. , Ltd.
Orthopedic · 139d
Cleared Apr 13, 2017
Additive Orthopaedics Locking Lattice Plate
K170214
Additive Orthopaedics, LLC
Orthopedic · 79d
Cleared Apr 07, 2017
ANTHEM™ Fracture System
K163361
Globus Medical, Inc.
Orthopedic · 128d
Cleared Mar 30, 2017
Alians Clavicle range
K170310
Newclip Technics
Orthopedic · 57d
Cleared Mar 24, 2017
NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand of DHS/DCS Plating System
K163425
Narang Medical USA Corporation
Orthopedic · 108d