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
433–456 of 1333
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
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