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
337–360 of 1322
Cleared Nov 07, 2019
DePuy Synthes 2.4mm LCP Straight Wrist Plate, Sterile
K192327
Synthes USA Products, LLC
Orthopedic · 72d
Cleared Oct 30, 2019
Treace Medical Concepts (TMC) Plating System
K192504
Treace Medical Concepts, Inc.
Orthopedic · 48d
Cleared Oct 16, 2019
Arthrex Minimally Invasive Ankle Fusion Plate
K190953
Arthrex, Inc.
Orthopedic · 188d
Cleared Oct 15, 2019
Arthrex Mini Comprehensive Fixation System – 1.4mm & 1.6mm Module
K191326
Arthrex, Inc.
Orthopedic · 152d
Cleared Oct 03, 2019
Arthrex Mini Comprehensive Fixation System – 2.0mm & 2.4mm Module
K191344
Arthrex, Inc.
Orthopedic · 136d
Cleared Sep 30, 2019
APTUS Wrist Spanning Plates 2.5
K191848
Medartis AG
Orthopedic · 82d
Cleared Sep 16, 2019
AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius Plates, AFFINITY – Variable Angle Distal Radius Screws
K191641
Industrias Medicas Sampedro S.A.S
Orthopedic · 89d
Cleared Sep 13, 2019
NCB Plating System Distal Femur and Proximal Tibia
K192217
Zimmer GmbH
Orthopedic · 29d
Cleared Aug 23, 2019
VariAx 2 System, VariAx 2 Mini Fragment System
K191412
Stryker GmbH
Orthopedic · 87d
Cleared Aug 22, 2019
NCB Polyaxial Locking Plate System
K192021
Zimmer GmbH
Orthopedic · 24d
Cleared Aug 12, 2019
Arsenal Plating System
K191009
Trilliant Surgical
Orthopedic · 118d
Cleared Aug 08, 2019
CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan Compression Staple System
K190385
In2bones USA, LLC
Orthopedic · 170d
Cleared Aug 06, 2019
OrthoPediatrics PediFoot Deformity Corrections System
K190992
OrthoPediatrics Corp.
Orthopedic · 113d
Cleared Aug 01, 2019
LOQTEQ VA Calcaneus Plate 3.5
K182818
Aap Implantate AG
Orthopedic · 302d
Cleared Jul 29, 2019
CoLink® Mini Plating System
K191535
In2bones USA, LLC
Orthopedic · 49d
Cleared Jul 23, 2019
DePuy Synthes Craniomaxillofacial Sternal Devices - MR Conditional
K190963
Synthes USA Products, LLC
Orthopedic · 102d
Cleared Jul 17, 2019
ORTHOLOC™ SPS Shoulder Plating System
K191711
Tornier, Inc.
Orthopedic · 21d
Cleared Jun 21, 2019
DePuy Synthes Plates and Screws Portfolio
K190750
DePuy Synthes
Orthopedic · 88d
Cleared Jun 19, 2019
LOQTEQ VA Foot Plates 2.5
K182785
Aap Implantate AG
Orthopedic · 261d
Cleared Jun 10, 2019
Arzzt Distal Radius and Ulna System
K182650
Truemed Group, LLC
Orthopedic · 259d
Cleared Jun 07, 2019
RIVAL View Plating Systems and Reduce Fracture Plating Systems
K190388
Orthofix Srl
Orthopedic · 108d
Cleared Jun 06, 2019
PROSTEP TBC Implant System
K183620
Wrightmedicaltechnologyinc
Orthopedic · 162d
Cleared May 14, 2019
ORTHOLOC™ 2 Lapidus with Rotation System
K190670
Wrightmedicaltechnologyinc
Orthopedic · 60d
Cleared May 03, 2019
MatrixRIB Fixation System
K190409
DePuy Synthes
Orthopedic · 71d