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
649–672 of 1322
Cleared Dec 02, 2013
1ST MTP PLATE
K133437
Osteomed
Orthopedic · 25d
Cleared Nov 19, 2013
A.L.P.S. CALCANEAL PLATING SYSTEM
K132898
Biomet Manufacturing Corp
Orthopedic · 64d
Cleared Nov 18, 2013
LOQTEQ HIGH TIBIA OSTEOTOMY PLATE 4.5
K131782
Aap Implantate AG
Orthopedic · 154d
Cleared Nov 18, 2013
FLOWER ANKLE PLATING SET
K133102
Flower Orthopedics Corporation
Orthopedic · 49d
Cleared Nov 04, 2013
ARIX HAND SYSTEM
K131566
Jeil Medical Corporation
Orthopedic · 158d
Cleared Nov 04, 2013
WOLF LONG BONE PLATE SYSTEM
K131834
Toby Orthopaedics
Orthopedic · 137d
Cleared Oct 29, 2013
2.5MM INLINE FUSION PLATE
K131867
Biomet, Inc.
Orthopedic · 127d
Cleared Oct 23, 2013
VARIAX 2 SYSTEM
K132502
Stryker Trauma AG
Orthopedic · 75d
Cleared Oct 08, 2013
SYNTHES 2.7MM AND 3.5MM VARIABLE ANGLE LCP MIDFOOT/HINDFOOT SYSTEM
K131186
Synthes USA Products, LLC
Orthopedic · 166d
Cleared Oct 03, 2013
AAP LOQTEQ PROXIMAL MEDIAL TIBIA PLATE 3.5
K132554
Aap Implantate AG
Orthopedic · 50d
Cleared Oct 03, 2013
LOCKING PLATE SYSTEM
K132642
Beijing Libeier Bio-Engineering Institute Co., Ltd.
Orthopedic · 38d
Cleared Sep 25, 2013
ARTHREX COMPRESSION PLATES
K130510
Arthrex, Inc.
Orthopedic · 210d
Cleared Sep 17, 2013
MAXLOCK EXTREME SYSTEM
K132591
Orthohelix Surgical Designs, Inc.
Orthopedic · 29d
Cleared Sep 05, 2013
ARIX FOOT SYSTEM
K131311
Jeil Medical Corporation
Orthopedic · 121d
Cleared Sep 05, 2013
ACUMED WRIST SPANNING PLATE
K131764
Acumed, LLC
Orthopedic · 80d
Cleared Aug 22, 2013
FLOWER SMALL AND MEDIUM IMPLANT SET
K131657
Flower Orthopedics Corporation
Orthopedic · 77d
Cleared Aug 09, 2013
METAFIX BLP PLATE, SIZE 31, LEFT, METAFIX BLP PLATE, SIZE 31,RIGHT
K132226
Merete Medical GmbH
Orthopedic · 23d
Cleared Aug 08, 2013
METALLIC LOCKING COMPRESSION BONE PLATES AND SCREWS SYSTEM
K131759
Tianjin Walkman Biomaterial Co., Ltd.
Orthopedic · 52d
Cleared Aug 07, 2013
INTEGRA TITANIUM BONE WEDGE
K131360
Ascension Orthopedic
Orthopedic · 86d
Cleared Aug 07, 2013
I.T.S. EXTREMITY FIXATION SYSTEMS
K131722
I.T.S. GmbH
Orthopedic · 56d
Cleared Aug 02, 2013
NORMED ANKLE FIX SYSTEM 4.0 AND NORMED ANKLE FIX PLUS SYSTEM 4.0
K123347
Normed Medizin-Technik GmbH
Orthopedic · 275d
Cleared Jul 19, 2013
STABILIZ FIXATION SYSTEM - SPL LOCKING SCREW
K130731
Stabiliz Orthopaedics, LLC
Orthopedic · 123d
Cleared Jul 03, 2013
ARTHREX DISTAL RADIUS PLATE SYSTEM
K131474
Arthrex, Inc.
Orthopedic · 42d
Cleared Jul 03, 2013
EMERGE MEDICAL LOCKING ONE-THIRD TUBULAR PLATE SYSTEM
K131480
Emerge Medical
Orthopedic · 42d