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..

1333
Total
1333
Cleared
115d
Avg days
1976
Since
1333 devices
673–696 of 1333
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
Cleared Jul 03, 2013
LAPIDUS PLATE, 3.5MM INLINE FUSION PLATE, 3.5MM MTP PLATE (LEFT AND RIGHT)
K131670
Biomet, Inc.
Orthopedic · 26d
Cleared Jun 25, 2013
DISTAL ULNA LOCKING PLATE (DUL), ULNA OSTEOTOMY LOCKING PLATE (UOL), 3.0 CANCELLOUS LOCKING SCREW, 3.0 CORTICAL LOCKING
K130008
I.T.S. GmbH
Orthopedic · 174d
Cleared Jun 19, 2013
UNIVERSAL DISTAL RADIUS SYSTEM
K130774
Newclip Technics
Orthopedic · 91d
Cleared Jun 18, 2013
OSTEOMED EXTREMILOCK FOOT PLATING SYSTEM
K131445
Osteomed LP
Orthopedic · 29d
Cleared Jun 10, 2013
ACUMED TOTALW RIST FUSION PLATING SYSTEM
K131380
Acumed, LLC
Orthopedic · 27d
Cleared Jun 07, 2013
4WEB OSTEOTOMY BONE WEDGE
K130185
4-Web, Inc.
Orthopedic · 133d
Cleared May 31, 2013
PELVIS II IMPLANT SYSTEM
K131132
Stryker Trauma AG
Orthopedic · 38d
Cleared May 21, 2013
ORTHOLOC(R) 3DI ANKLE PLATING SYSTEM
K131093
Wrightmedicaltechnologyinc
Orthopedic · 33d
Cleared May 08, 2013
GRIDLOCK PLATING SYSTEM
K130964
Trilliant Surgical, Ltd.
Orthopedic · 30d
Cleared Apr 19, 2013
DOUBLE ENGINE BONE PLATE AND SCREW SYSTEMS
K130108
Xiamen Double Engine Medical Material Co., Ltd.
Orthopedic · 93d
Cleared Apr 05, 2013
ARTHREX FRACTURE PLATES
K123241
Arthrex, Inc.
Orthopedic · 170d
Cleared Apr 05, 2013
LOCKING BONE PLATES AND SCREWS
K130340
Weigao Orthopaedic Device Co., Ltd.
Orthopedic · 53d
Cleared Mar 29, 2013
FLOWER SMALL AND MEDIUM BONE IMPLANTS
K123562
Flower Orthopedics Corporation
Orthopedic · 130d