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
457–480 of 1319
Cleared Jun 09, 2015
APTUS Wrist 2.5 System
K142906
Medartis AG
Orthopedic · 246d
Cleared May 20, 2015
BIOFOAM Bone Wedge
K142724
Wrightmedicaltechnologyinc
Orthopedic · 239d
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 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
Cleared Mar 24, 2015
Tarsa-Link Wedge Fixation System
K150368
Life Spine
Orthopedic · 40d
Cleared Mar 23, 2015
Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws)
K150099
Synthes USA Products, LLC
Orthopedic · 62d
Cleared Mar 04, 2015
Zimmer Plates and Screws System (ZPS) - Non-sterile ZPS
K143331
Zimmer, Inc.
Orthopedic · 104d
Cleared Feb 23, 2015
Zimmer Periarticular Plating System
K150121
Zimmer, Inc.
Orthopedic · 34d
Cleared Jan 23, 2015
Acumed Small Fragment Base Set
K143394
Acumed, LLC
Orthopedic · 58d
Cleared Jan 16, 2015
Arthrex Fracture System
K143139
Arthrex, Inc.
Orthopedic · 74d
Cleared Dec 18, 2014
VLP Mini-Mod Small Bone Plating System 1.5mm Plates and Screws
K143050
Smith & Nephew, Inc.
Orthopedic · 56d
Cleared Dec 05, 2014
TOTAL COMPRESSION PLATING SYSTEM
K143025
Wrightmedicaltechnologyinc
Orthopedic · 45d
Cleared Nov 28, 2014
Zimmer Plates and Screws (ZPS) - Non Sterile Plate Line Extensions, Sterile/Non-Sterile ZPS / Screws and Washers
K143066
Zimmer, Inc.
Orthopedic · 35d
Cleared Nov 12, 2014
Zimmer Plates and Screws (ZPS), Forte Screws
K142836
Zimmer, Inc.
Orthopedic · 43d
Cleared Oct 22, 2014
Zimmer Periarticular Plating System
K142579
Zimmer, Inc.
Orthopedic · 37d
Cleared Sep 26, 2014
PRO-LINK WEDGE SYSTEM
K141905
Life Spine
Orthopedic · 73d
Cleared Aug 29, 2014
DEPUY SYNTHES TOMOFIX OSTEOTOMY SYSTEM
K141796
Synthes USA Products, LLC
Orthopedic · 57d
Cleared Aug 21, 2014
VALOR HINDFOOT FUSION NAIL SYSTEM
K142121
Wrightmedicaltechnologyinc
Orthopedic · 17d
Cleared Aug 15, 2014
ARTHREX ANKLE FUSION PLATING SYSTEM
K141735
Arthrex, Inc.
Orthopedic · 49d
Cleared Aug 14, 2014
ZIMMER PLATES AND SCREWS SYSTEM(ZPS)- NON-STERILE PLATES AND SCREWS
K140508
Zimmer, Inc.
Orthopedic · 167d