ClearanceBrief
Panels › Orthopedic › Product code HRS · Class 2

Plate, Fixation, Bone

Regulation 888.3030

64510(k)s in 12 months (1,334 all time)
20recalls in 12 months (288 all time)
277recalls that name a 510(k)
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Top companies in HRS

Company510(k)sRecalls
Synthes1048
Smith & Nephew3716
Biomet2128
Wrightmedicaltechnologyinc450
Zimmer GmbH3212
Arthrex, Inc.403
Wright Medical Technology Inc043
DePuy Orthopaedics, Inc.1814
Medartis AG320
TriMed, Inc.256
Decided510(k)Device and applicantCode
Mar 20, 2013K123832OIC DISTAL RADIUS PLATING SYSTEM, OIC PROXIMAL HUMERUS PLATING SYSTEM, OIC CLAVICLE PLATING SYSTEM, THE OIC SMALL FRAGME
The Orthopaedic Implant Company (Oic)
HRS
Mar 20, 2013K123403AXSOS PROXIMAL LATERAL TIBIA LONG PLATES
Stryker Trauma AG
HRS
Mar 11, 2013K123875AAP RADIUS SET 2.5
Aap Implantate AG, DE
HRS
Mar 5, 2013K130116SUPERIOR LATERAL VARIAX CLAVICLE PLATE
Stryker Trauma AG
HRS
Feb 28, 2013K122936ANKLE TRAUMA SYSTEM
Orthopro, LLC
HRS
Feb 27, 2013K130061PICCOLO COMPOSITE PLATE SYSTEM
CarboFix Orthopedics , Ltd., IL
HRS
Feb 15, 2013K123525GRIDLOCK PLATING SYSTEM
Trilliant Surgical, Ltd.
HRS
Feb 14, 2013K123918MOTIONLOC SCREW FOR NCB POLYAXIAL LOCKING PLATE SYSTEM
Zimmer, Inc.
HRS
Feb 13, 2013K121826INTEGRA PROXIMAL HUMERAL PLATE SYSTEM
Ascension Orthopedics, Inc.
HRS
Jan 25, 2013K123055SMITH & NEPHEW, INC SCREW AND PLATE SYSTEM INSTRUMENTATION
Smith & Nephew, Inc.
HRS
Jan 18, 2013K122310GEMINUS FOSSA SPECIFIC PLATE SYSTEM
Skeletal Dynamics, LLC
HRS
Jan 17, 2013K102689CONVENTUS ORTHOPAEDICS FRACTURE FIXATION SYSTEM
Conventus Orthopaedics
HRS
Dec 21, 2012K123000INTEGRA TOTAL FOOT SYSTEMS
Integra LifeSciences Corporation
HRS
Dec 14, 2012K123203MAXLOCK EXTREME SYSTEM MODEL MXL
Orthohelix Surgical Designs, Inc.
HRS
Dec 7, 2012K121495LOQTEQ PROXIMAL HUMERUS PLATE 3.5, SHORT LOQTEQ PROXIMAL HUMERUS PLATE 3.5, LONG
Aap Implantate AG, DE
HRS
Nov 28, 2012K122334CHECKMATE SMALL BONE FUSION SYSTEM
Arthrosurface, Inc.
HRS
Nov 27, 2012K120787MERETE LOCKING BONE PLATE SYSTEM III
Merete Medical GmbH
HRS
Nov 27, 2012K120651STABILIZ FIXATION SYSTEM
Stabiliz Orthopaedics, LLC
HRS
Nov 26, 2012K120409PICCOLO COMPOSITE PLATE SYSTEM
CarboFix Orthopedics , Ltd., IL
HRS
Nov 19, 2012K122538ACUMED PELVIC BONE PLATE SYSTEM
Acumed, LLC
HRS
Nov 19, 2012K121494LOQTEQ DISTAL LATERAL FEMUR PLATE 4.5 (LEFT AND RIGHT VERSION) LOQREQ CORTICAL SCREW 4.5 T25, SELF-TAPPING
Aap Implantate AG, DE
HRS
Nov 14, 2012K122860KLS MARTIN RECON TALON
KLS Martin L.P.
HRS
Nov 8, 2012K113601AAP LOQTEQ DISTAL MEDIAL TIBIA PLATE 3.5 SYSTEM
Aap Implantate AG, DE
HRS
Oct 31, 2012K113602AAP LOQTEQ PROXIMAL LATERAL TIBIA PLATE 4.5 SYSTEM
Aap Implantate AG, DE
HRS
Oct 12, 2012K122293PIONEER STERNAL CABLE PLATE SYSTEM
Pioneer Surgical Technology, Inc.
HRS
Oct 12, 2012K121651ORTHOLOC 3DI MIDFOOT/FLATFOOT SYSTEM
Wrightmedicaltechnologyinc
HRS
Oct 3, 2012K122737GEMINUS FOSSA SPECIFIC PLATE SYSTEM
Skeletal Dynamics, LLC
HRS
Oct 1, 2012K122308AXSOS DISTAL LATERAL FEMUR TS LONG PLATES
Howmedica Osteonics Corp., Dba Stryker Orthopaedics
HRS
Oct 1, 2012K121672AFT PROXIMAL HUMERUS FRACTURE PLATE
Shoulder Options, Inc.
HRS
Oct 1, 2012K121425ORTHOLOC 3DI ANKLE FUSION PLATING SYSTEM
Wrightmedicaltechnologyinc
HRS
Sep 26, 2012K122623SHORT LATERAL SUPERIOR CLAVICLE PLATE, LEFT AND RIGHT MODEL 3017-000 (LEFT) AND 3018-000 (RIGHT); 6 HOLE MEDIUM MIDSHAFT
Advanced Orthopaedic Solutions, Inc.
HRS
Sep 19, 2012K121302BIOMET MICROFIXATION STERNAL CLOSURE SYSTEM
Biomet Microfixation
HRS
Sep 6, 2012K122005MAXLOCK EXTREME SYSTEM
Orthohelix Surgical Designs, Inc.
HRS
Sep 6, 2012K113648LOQTEQ LARGE FRAGMENT SET LOQTEQ CORTICAL SCREW 4.5, SMALL HEAD, T25, SELF TAPPING LOQTEQ CORTICAL SCREW 4.5, T25, SELF
Aap Implantate AG, DE
HRS
Aug 30, 2012K113652LOQTEQ SMALL FRAGMENT SET LOQTEQ CORTICAL SCREW3.5, SMALL HEAD, T15, SELF TAPPING LOQTEQ CORTICAL SCREW 3.5, T15, SELF T
Aap Implantate AG, DE
HRS
Aug 20, 2012K121452GRIDLOCK PLATING SYSTEM
Trilliant Surgical, Ltd.
HRS
Jul 26, 2012K120016PIONEER STERNAL ASSIST IMPLANT SYSTEM
Pioneer Surgical Technology, Inc.
HRS
Jul 13, 2012K120903CONGRUENT BONE PLATE SYSTEM: ACU-LOC 2 PLATE
Acumed, LLC
HRS
Jul 6, 2012K121601SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM-ANTEROLATERAL DISTAL TIBIA PLATE
Synthes USA
HRS
Jun 18, 2012K120854SYNTHES VA LCP ANKLE TRAUMA SYSTEM
Synthes USA
HRS
Jun 13, 2012K121437MINI MAXLOCK EXTREME PLATING SYSTEM
Orthohelix Surgical Designs, Inc.
HRS
Jun 12, 2012K120772NCB PERIPROSTHETIC TROCHANTER PLATES AND SCREWS, NCB CABLE BUTTON FOR NCB OPLYAXIAL LOCKING PLATE
Zimmer GmbH
HRS
Jun 4, 2012K120689SYNTHES 3.5 MM VA-LCP PROXIMAL TIBIA PLATE SYSTEM
Synthes (USA) Products, LLC
HRS
May 29, 2012K120360ORTHO SOLUTIONS TRAUMA PLATES FOR OSTEOSYSNTHESIS
Ortho Solutions Limited
HRS
May 10, 2012K112794EOS SMALL BONE FIXATION SYSTEM
TriMed, Inc.
HRS
May 8, 2012K120717SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (MEDICAL AND POSTEROLATERAL DISTAL HUMERUS PLATES)
Synthes USA
HRS
May 3, 2012K120359ORTHOLOC 3DI HALLUX SYSTEM
Wrightmedicaltechnologyinc
HRS
May 2, 2012K111008MICROWARE BONE PLATES AND BONE SCREW
Microware Precision Co., Ltd., TW
HRS
Apr 27, 2012K120108APTUS PROXIMAL HUMERUS SYSTEM
Medartis AG
HRS
Apr 25, 2012K113760VARIAX SUPERIOR AND ANTERIOR, LATERAL AND MIDSHAFT CLAVICLE PLATES VARIAX AIMING BLOCKS & JOYSTICK
Howmedica Osteonics Corp., Dba Stryker Orthopaedics
HRS

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