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
697–720 of 1322
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 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
Cleared Nov 14, 2012
KLS MARTIN RECON TALON
K122860
KLS-Martin L.P.
Orthopedic · 57d
Cleared Nov 08, 2012
AAP LOQTEQ DISTAL MEDIAL TIBIA PLATE 3.5 SYSTEM
K113601
Aap Implantate AG
Orthopedic · 339d
Cleared Oct 31, 2012
AAP LOQTEQ PROXIMAL LATERAL TIBIA PLATE 4.5 SYSTEM
K113602
Aap Implantate AG
Orthopedic · 331d
Cleared Oct 12, 2012
ORTHOLOC 3DI MIDFOOT/FLATFOOT SYSTEM
K121651
Wrightmedicaltechnologyinc
Orthopedic · 129d
Cleared Oct 12, 2012
PIONEER STERNAL CABLE PLATE SYSTEM
K122293
Pioneer Surgical Technology, Inc.
Orthopedic · 73d
Cleared Oct 03, 2012
GEMINUS FOSSA SPECIFIC PLATE SYSTEM
K122737
Skeletal Dynamics, LLC
Orthopedic · 27d
Cleared Oct 01, 2012
ORTHOLOC 3DI ANKLE FUSION PLATING SYSTEM
K121425
Wrightmedicaltechnologyinc
Orthopedic · 140d
Cleared Oct 01, 2012
AFT PROXIMAL HUMERUS FRACTURE PLATE
K121672
Shoulder Options, Inc.
Orthopedic · 117d
Cleared Oct 01, 2012
AXSOS DISTAL LATERAL FEMUR TS LONG PLATES
K122308
Howmedica Osteonics Corp., Dba Stryker Orthopaedics
Orthopedic · 61d
Cleared Sep 26, 2012
SHORT LATERAL SUPERIOR CLAVICLE PLATE, LEFT AND RIGHT MODEL 3017-000 (LEFT) AND 3018-000 (RIGHT)
K122623
Advanced Orthopaedic Solutions, Inc.
Orthopedic · 29d
Cleared Sep 19, 2012
BIOMET MICROFIXATION STERNAL CLOSURE SYSTEM
K121302
Biomet Microfixation
Orthopedic · 141d
Cleared Sep 06, 2012
LOQTEQ LARGE FRAGMENT SET LOQTEQ CORTICAL SCREW 4.5, SMALL HEAD, T25, SELF TAPPING LOQTEQ CORTICAL SCREW 4.5, T25, SELF
K113648
Aap Implantate AG
Orthopedic · 269d