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..

1319
Total
1319
Cleared
116d
Avg days
1976
Since
1319 devices
409–432 of 1319
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 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 Jun 22, 2017
VariAx 2 Compression Plating System
K170727
Stryker GmbH
Orthopedic · 105d
Cleared Jun 16, 2017
BioPro Foot Plating Systems
K162674
Biopro, Inc.
Orthopedic · 263d
Cleared Jun 14, 2017
EVOS Small Fragment Lower Extremity Plates
K170457
Smith & Nephew, Inc.
Orthopedic · 119d
Cleared May 08, 2017
VariAx 2 Foot System
K170771
Stryker GmbH
Orthopedic · 55d
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 07, 2017
ANTHEM™ Fracture System
K163361
Globus Medical, Inc.
Orthopedic · 128d
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
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 03, 2017
AxSOS 3 Ti
K162439
Stryker GmbH
Orthopedic · 156d
Cleared Jan 26, 2017
ORTHOLOC® 3Di Ankle Fracture Plating System
K163044
Wrightmedicaltechnologyinc
Orthopedic · 87d
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 Nov 23, 2016
aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5
K161696
Aap Implantate AG
Orthopedic · 156d
Cleared Nov 22, 2016
LOQTEQ® VA Distal Tibia Plate System: LOQTEQ® VA Distal Medial Tibia Plate 3.5
K161747
Aap Implantate AG
Orthopedic · 151d