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
673–696 of 1322
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
Cleared Mar 28, 2013
BIOMET RECONSTRUCTIVE WEDGES MODEL 110003660-99, 110003797-831
K122770
Biomet Manufacturing Corp
Orthopedic · 199d
Cleared Mar 28, 2013
AXSOS 3 TI LOCKING PLATE SYSTEM
K123964
Stryker Trauma AG
Orthopedic · 92d
Cleared Mar 22, 2013
VARIAX 2 COMPRESSION PLATING SYSTEM
K130009
Stryker Trauma AG
Orthopedic · 79d
Cleared Mar 20, 2013
AXSOS PROXIMAL LATERAL TIBIA LONG PLATES
K123403
Stryker Trauma AG
Orthopedic · 135d
Cleared Mar 20, 2013
OIC DISTAL RADIUS PLATING SYSTEM, OIC PROXIMAL HUMERUS PLATING SYSTEM, OIC CLAVICLE PLATING SYSTEM, THE OIC SMALL FRAGME
K123832
The Orthopaedic Implant Company (Oic)
Orthopedic · 97d
Cleared Mar 11, 2013
AAP RADIUS SET 2.5
K123875
Aap Implantate AG
Orthopedic · 84d
Cleared Mar 05, 2013
SUPERIOR LATERAL VARIAX CLAVICLE PLATE
K130116
Stryker Trauma AG
Orthopedic · 48d
Cleared Feb 28, 2013
ANKLE TRAUMA SYSTEM
K122936
Orthopro, LLC
Orthopedic · 157d
Cleared Feb 27, 2013
PICCOLO COMPOSITE PLATE SYSTEM
K130061
CarboFix Orthopedics , Ltd.
Orthopedic · 48d
Cleared Feb 15, 2013
GRIDLOCK PLATING SYSTEM
K123525
Trilliant Surgical, Ltd.
Orthopedic · 92d
Cleared Feb 14, 2013
MOTIONLOC SCREW FOR NCB POLYAXIAL LOCKING PLATE SYSTEM
K123918
Zimmer, Inc.
Orthopedic · 57d