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
697–720 of 1333
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
Cleared Feb 13, 2013
INTEGRA PROXIMAL HUMERAL PLATE SYSTEM
K121826
Ascension Orthopedics, Inc.
Orthopedic · 237d
Cleared Jan 25, 2013
SMITH & NEPHEW, INC SCREW AND PLATE SYSTEM INSTRUMENTATION
K123055
Smith & Nephew, Inc.
Orthopedic · 116d
Cleared Jan 18, 2013
GEMINUS FOSSA SPECIFIC PLATE SYSTEM
K122310
Skeletal Dynamics, LLC
Orthopedic · 170d
Cleared Jan 17, 2013
CONVENTUS ORTHOPAEDICS FRACTURE FIXATION SYSTEM
K102689
Conventus Orthopaedics
Orthopedic · 853d
Cleared Dec 21, 2012
INTEGRA TOTAL FOOT SYSTEMS
K123000
Integra LifeSciences Corporation
Orthopedic · 85d
Cleared Dec 14, 2012
MAXLOCK EXTREME SYSTEM MODEL MXL
K123203
Orthohelix Surgical Designs, Inc.
Orthopedic · 63d
Cleared Dec 07, 2012
LOQTEQ PROXIMAL HUMERUS PLATE 3.5, SHORT LOQTEQ PROXIMAL HUMERUS PLATE 3.5, LONG
K121495
Aap Implantate AG
Orthopedic · 200d
Cleared Nov 28, 2012
CHECKMATE SMALL BONE FUSION SYSTEM
K122334
Arthrosurface, Inc.
Orthopedic · 118d
Cleared Nov 27, 2012
STABILIZ FIXATION SYSTEM
K120651
Stabiliz Orthopaedics, LLC
Orthopedic · 270d
Cleared Nov 27, 2012
MERETE LOCKING BONE PLATE SYSTEM III
K120787
Merete Medical GmbH
Orthopedic · 257d
Cleared Nov 26, 2012
PICCOLO COMPOSITE PLATE SYSTEM
K120409
CarboFix Orthopedics , Ltd.
Orthopedic · 291d
Cleared Nov 19, 2012
LOQTEQ DISTAL LATERAL FEMUR PLATE 4.5 (LEFT AND RIGHT VERSION) LOQREQ CORTICAL SCREW 4.5 T25, SELF-TAPPING
K121494
Aap Implantate AG
Orthopedic · 182d
Cleared Nov 19, 2012
ACUMED PELVIC BONE PLATE SYSTEM
K122538
Acumed, LLC
Orthopedic · 90d