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
457–480 of 1322
Cleared Mar 17, 2017
Olecranon Plating System
K162898
Miami Device Solutions, LLC
Orthopedic · 151d
Cleared Mar 16, 2017
Y3 Proximal Femoral Plate System
K163003
Pega Medical, Inc.
Orthopedic · 139d
Cleared Mar 13, 2017
ORTHOLOC® 3Di Small Bones Plating
K163039
Wrightmedicaltechnologyinc
Orthopedic · 133d
Cleared Mar 09, 2017
Level One Hand Plating System
K170124
KLS-Martin L.P.
Orthopedic · 55d
Cleared Feb 21, 2017
AlignMATE™ Lapidus Arthrodesis System
K162391
Arthrosurface, Inc.
Orthopedic · 179d
Cleared Feb 21, 2017
VariAx Distal Radius Plating System, VariAx 2 System
K162841
Stryker GmbH
Orthopedic · 133d
Cleared Feb 09, 2017
APTUS® Coronoid 2.0
K161861
Medartis AG
Orthopedic · 218d
Cleared Feb 09, 2017
DePuy Synthes 2.4/2.7mm VA LCP Two-Column Volar Distal Radius Plate, Extra-Long
K163046
DePuy Synthes
Orthopedic · 100d
Cleared Feb 03, 2017
AxSOS 3 Ti
K162439
Stryker GmbH
Orthopedic · 156d
Cleared Jan 26, 2017
dynaMX™ Compression Plate
K161303
Mx Orthopedics, Corp.
Orthopedic · 261d
Cleared Jan 26, 2017
ORTHOLOC® 3Di Ankle Fracture Plating System
K163044
Wrightmedicaltechnologyinc
Orthopedic · 87d
Cleared Jan 10, 2017
osteo-WEDGE II ® Open Wedge Bone Locking Plate System
K162179
Graham Medical Technologies, LLC Dba Gramedica
Orthopedic · 159d
Cleared Dec 21, 2016
VLP MINI-MOD 2.0mm Column Plates
K163086
Smith & Nephew, Inc.
Orthopedic · 48d
Cleared Dec 09, 2016
Medline UNITE® Ankle Fracture Plating System
K162829
Medline Industries, Inc.
Orthopedic · 63d
Cleared Dec 09, 2016
Biomet Microfixation RibFix Blu Thoracic Fixation System
K162974
Biomet Microfixation
Orthopedic · 45d
Cleared Nov 23, 2016
aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5
K161696
Aap Implantate AG
Orthopedic · 156d
Cleared Nov 23, 2016
Biomet Microfixation SternaLock 360 Sternal Closure System
K163007
Biomet Microfixation
Orthopedic · 26d
Cleared Nov 22, 2016
LOQTEQ® VA Distal Tibia Plate System: LOQTEQ® VA Distal Medial Tibia Plate 3.5
K161747
Aap Implantate AG
Orthopedic · 151d
Cleared Nov 18, 2016
EVOS Small Fragment Plating System
K162078
Smith & Nephew, Inc.
Orthopedic · 114d
Cleared Nov 15, 2016
VLP Wrist Fracture System
K161665
Smith & Nephew, Inc.
Orthopedic · 152d
Cleared Nov 04, 2016
LOQTEQ Distal Fibula Plate 3.5, Cancellous Screw 4.0, Washer
K161703
Aap Implantate AG
Orthopedic · 137d
Cleared Nov 04, 2016
AOS Small Fragment Plating System
K161913
Advanced Orthopaedic Solutions, Inc. (Aos)
Orthopedic · 115d
Cleared Nov 03, 2016
MatrixRIB Fixation System
K161590
Synthes USA Products, LLC
Orthopedic · 147d
Cleared Oct 31, 2016
Footmotion Plating System
K161448
Newclip Technics
Orthopedic · 159d