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
529–552 of 1322
Cleared Aug 28, 2015
Arthrex Fracture Plates
K151732
Arthrex, Inc.
Orthopedic · 63d
Cleared Aug 27, 2015
PRCT2
K143721
Fx Solutions
Orthopedic · 241d
Cleared Aug 13, 2015
Airlock® osteosynthesis plate system
K151277
Novastep
Orthopedic · 91d
Cleared Aug 13, 2015
Conventus PRS System
K151379
Conventus Orthopaedics, Inc.
Orthopedic · 83d
Cleared Aug 12, 2015
RECON system
K151407
Normed Medizin-Technik GmbH
Orthopedic · 78d
Cleared Aug 10, 2015
WASTON Metallic Bone Plate and Screw Systems
K151057
Changzhou Waston Medical Appliance Co., Ltd.
Orthopedic · 112d
Cleared Aug 06, 2015
Medline Foot Plates and Screws
K151235
Medline Industries, Inc.
Orthopedic · 87d
Cleared Aug 06, 2015
VariAx 2 One-Third Tubular Plating System
K151879
Stryker GmbH
Orthopedic · 28d
Cleared Aug 03, 2015
Metallic Locking Bone Plate and Screw
K142943
Canwell Medical Co., Ltd.
Orthopedic · 297d
Cleared Jun 30, 2015
AUXEIN BRAND OF Bone Plates and Bone Screws & AUXEIN Brand of DCS Plate System AUXEIN brand of Locking Plates and Locking Screws
K141680
Auxein Medical
Orthopedic · 372d
Cleared Jun 24, 2015
VariAx 2 Wrist Fusion System
K151178
Stryker Trauma AG
Orthopedic · 51d
Cleared Jun 09, 2015
APTUS Wrist 2.5 System
K142906
Medartis AG
Orthopedic · 246d
Cleared Jun 05, 2015
Metallic Locking Bone Plate and Screw System
K143002
Changzhou Dingjian Medical Appliance Co., Ltd.
Orthopedic · 228d
Cleared May 29, 2015
Piccolo Composite Plate System
K143496
CarboFix Orthopedics , Ltd.
Orthopedic · 171d
Cleared May 20, 2015
BIOFOAM Bone Wedge
K142724
Wrightmedicaltechnologyinc
Orthopedic · 239d
Cleared May 12, 2015
Dorsal Spanning Plate
K150675
Skeletal Dynamics, LLC
Orthopedic · 57d
Cleared Apr 30, 2015
G3 Active Plate Large Fragment System
K150649
Genesis Fracture Care, Inc.
Orthopedic · 49d
Cleared Apr 29, 2015
Arthrex Plates, Screws, and Staples
K150456
Arthrex, Inc.
Orthopedic · 68d
Cleared Apr 29, 2015
DARCO Locking Bone Plate System
K150520
Wrightmedicaltechnologyinc
Orthopedic · 58d
Cleared Apr 09, 2015
APTUS Foot System
K142581
Medartis AG
Orthopedic · 206d
Cleared Apr 06, 2015
Acumed Ankle Plating System
K143385
Acumed, LLC
Orthopedic · 131d
Cleared Apr 06, 2015
Airlock osteosynthesis plate system
K143523
Novastep
Orthopedic · 115d
Cleared Apr 03, 2015
Arthrex Distal Radius System
K143749
Arthrex, Inc.
Orthopedic · 93d
Cleared Mar 30, 2015
DEPUY SYNTHES VARIABLE ANGLE LOCKING HAND SYSTEM
K141527
Synthes (Usa)
Orthopedic · 294d