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530 FDA 510(k) clearances · Product code

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RecordFirmDate
AOS ES Retrograde Femoral Nail (K191598)Advanced Orthopaedic Solutions, Inc.2019-07-18
Zimmer Guide Wire Devices (K191238)Zimmer, Inc.2019-07-05
T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws System, IMN Instruments System (K191271)Stryker Trauma GmbH2019-06-11
Syntec Femoral Nail System (K181296)Syntec Scientific Corporation2019-04-11
PRECICE® BONE TRANSPORT™ System (K182170)Nuvasive Specialized Orthopedics, Inc.2019-02-05
Estremo Citieffe Nailing System (K181540)Citieffe S.R.L.2019-01-16
Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail System (K182307)Paragon 28, Inc.2019-01-14
Affixus Hip Fracture Nail (K183162)Biomet, Inc.2018-12-14
Affixus Natural Nail System Humeral Nail (K181827)Zimmer GmbH2018-12-14
Panta 2 Arthrodesis Nail System (K181639)Integra LifeSciences Corporation2018-11-02
OsteoBridge™ IDSF System (K181026)Merete GmbH2018-10-17
X-BOLT Hip Fracture Fixation System (K181640)X-Bolt Orthopaedics2018-10-12
Double Medical Femoral Nail System (K172830)Double Medical Technology, Inc.2018-08-24
OIC Intramedullary Nail System (K181184)The Orthopaedic Implant Company2018-07-27
Arthrex FibuLock Nail (K173656)Arthrex, Inc.2018-07-26
Apex Femoral Nailing System (K181375)Orthoxel2018-07-17
T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System (K180436)Stryker Trauma GmbH2018-06-06
OrthoPediatrics PediNail Intramedullary Platform (K172583)Orthopediatrics, Inc.2018-05-10
Agile Nail (K172699)Orthofix Srl2018-04-23
PRECICE STRYDE System (K180503)Nuvasive Specialized Orthopedics, Inc.2018-04-03
TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis System (K173811)In2bones Sas2018-03-15
Talon DistalFix Humeral Nail (K173255)Orthopedic Designs North America, Inc.2018-02-22
Ins Hilden Humeral Arzzt, Ins Hilden Cannulated Tibial Arzzt, Ins Hilden Femoral Arzzt & Ins Hilden Retrograde Femoral Arzzt (K172189)Truemed Group, LLC2018-01-16
T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System (K172774)Stryker Trauma GmbH2018-01-12
AUTOBAHN Nailing System (K171108)Globus Medical, Inc.2017-12-29
Piccolo Composite Nailing System (K173652)CarboFix Orthopedics , Ltd.2017-12-28
Apex Tibial Nailing System (K170972)Orthoxel2017-12-20
ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System (K173458)Orthofix Srl2017-12-07
PRECICE System (K173129)Nuvasive Specialized Orthopedics, Inc.2017-12-01
DePuy Synthes Femoral Recon Nail System (K172157)Synthes (USA) Products, LLC2017-11-14
DynaNail TTC Fusion System (K171376)MedShape, Inc.2017-11-02
Flex-Thread Fibula Pin System (K172943)Intrafuse, LLC2017-10-30
NOVOS-NAIL Limb Lengthening System (LLS) (K163653)Smith & Nephew2017-10-13
PRECICE System (K172628)Nuvasive Specialized Orthopedics, Inc.2017-09-25
Shotel Ankle Arthrodesis Nail System (K163627)Biopro, Inc.2017-09-14
PRECICE UNYTE System (K172061)Nuvasive Specialized Orthopedics, Inc.2017-08-24
Zimmer Natural Nail System (K172114)Zimmer, Inc.2017-08-10
SIGN IM Nail (K163589)Sign Fracture Care International2017-07-20
PRECICE Intramedullary Limb Lengthening System (K170169)Nuvasive Specialized Orthopedics, Inc.2017-06-09
SYNTEC HUMERAL NAIL SYSTEM (K161327)Syntec Scientific Corporation2017-06-08
PRECICE UNYTE CoCr System (K162927)Nuvasive Specialized Orthopedics, Inc.2017-04-06
Flex-Thread Clavicle Pin System (K163488)Intrafuse, LLC2017-03-20
PRECICE Intramedullary Limb Lengthening System (K170346)Nuvasive Specialized Orthopedics, Inc.2017-03-07
Sonoma Fifth Metatarsal Repair System (K161371)Sonoma Orthopedic Products, Inc.2017-02-24
FITBONE TAA (K163368)Wittenstein Intens GmbH2017-01-26
ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System (K161466)Orthofix Srl2017-01-24
AOS Small Bone Nailing System (K163014)Advanced Orthopaedic Solutions, Inc. (Aos)2017-01-24
TRIGEN Low Profile Bone Screws (K161264)Smith & Nephew, Inc.2016-11-23
GAP ENDO-EXO MEDULLARY SYSTEM (K160545)Pega Medical, Inc.2016-11-23
Renovo Life Small Bone IM Nail System (K161254)Renovo Life, LLC2016-11-07
DePuy Synthes TFNA Augmentation System (K160167)Synthes (USA) Products, LLC2016-09-26
PRECICE Intramedullary Limb Lengthening System (K160325)Ellipse Technologies, Inc.2016-04-04
PRECICE Trauma Nail System (K160267)Ellipse Technologies, Incorporated2016-03-31
Sonoma Fibula Repair System (K160069)Sonoma Orthopedics Products, Inc.2016-03-10
Piccolo Composite® Nailing System (K153536)CarboFix Orthopedics , Ltd.2016-01-06
PRECICE Trauma Nail System (K152370)Ellipse Technologies, Incorporated2015-12-22
WASTON Metallic Intramedullary Nail System (K151062)Changzhou Waston Medical Appliance Co., Ltd.2015-12-17
Cardinal Health Trochanteric IM Nail System (K150769)Cardinalhealth2015-12-14
SIGN Hip Construct (SHC) (K152757)Sign Fracture Care International2015-11-13
Talon DistalFix Antegrade/Retrograde Femoral Nail (K152295)Orthopedic Designs North America, Inc.2015-11-03
Small Bone Nail Implant (K151456)Vilex IN Tennessee, Inc.2015-10-29
GPC Intramedullary Nailing Systems (K143245)Gpc Medical Limited2015-09-30
Piccolo Composite Nailing System (K151010)CarboFix Orthopedics , Ltd.2015-07-28
The Simple Locking IntraMedullary (SLIM) System (K143355)Pega Medical, Inc.2015-07-10
OIC Intramedullary Nail System (K150655)Orthopaedic Implant Company2015-07-09
PRECICE Intramedullary Limb Lengthening System (K151131)Ellipse Technologies, Incorporated2015-06-19
Affixus Tibial Nailing System (K150867)Biomet, Inc.2015-06-10
AOS Clavicle Intramedullary Device (K143204)Advanced Orthopaedic Solutions, Inc.2015-06-03
ITST Intertrochanteric/Subtrochanteric Fixation System (K143321)Zimmer, Inc.2015-05-29
CalcaNail Orthopedic Arthrodesis Nail (K150471)Fournitures Hospitalieres Industrie2015-05-22
CalcaNail Orthopedic Nail (K150463)Fournitures Hospitalieres Industrie2015-05-22
PRECICE Intramedullary Limb Lengthening System (K150656)Ellipse Technologies, Incorporated2015-04-23
MICRONAIL Distal Radius System (K150073)Wrightmedicaltechnologyinc2015-02-10
OsteoBridge IDSF - Intramedullary Diaphyseal Segmental Defect Fixation Rod System (K142451)Merete Medical GmbH2015-02-09
Acumed Small Bone IM Nail System (K143276)Acumed, LLC2015-02-05
Sonoma Fibula Repair System (K142945)Sonoma Orthopedic Products, Inc.2015-01-22
PRECISE Trauma Nail System (K142599)Ellipse Technologies, Incorporated2015-01-16
ORTHOFIX ANKLE HINDFOOT NAILING SYSTEM (K141571)Orthofix Srl2014-11-12
INS HILDEN TIBIAL ARZZT (K133166)Truemed Group, LLC2014-11-06
VALOR Hindfoot Fusion Nail System (K142602)Wrightmedicaltechnologyinc2014-10-22
ZIMMER M/DN INTRAMEDULLARY FIXATION SYSTEM (K142281)Zimmer, Inc.2014-10-22
RESIDUAL LIMB LENGTHENING SYSTEM (K141739)Ellipse Technologies, Inc.2014-10-07
EMERGE MEDICAL IM NAIL SYSTEM (K141347)Emerge Medical2014-10-02
INTRAMEDULLARY NAIL AND SCREWS-NEONAIL (K141103)Neoortho Produtos Ortopedicos S/A2014-09-23
AOS 6.5MM CAPTURED, FULLY THREADED CANCELLOUS SCREW (K141228)Advanced Orthopaedic Solutions, Inc.2014-07-08
FLOW-NAIL (K140601)Flow-Fx, LLC2014-07-02
PRECICE TRAUMA NAIL SYSTEM (K141447)Ellipse Technologies, Inc.2014-06-30
DOUBLE ENGINE INTRAMEDDULLARY NAIL SYSTEM (K131609)Xiamen Double Engine Medical Material Co., Ltd.2014-05-21
PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM (K141023)Ellipse Technologies, Inc.2014-05-20
SYNTHES SYNSONIC ULNA NAIL (K131984)Synthes (Usa)2014-03-31
METALLIC INTRAMEDULLARY NAIL SYSTEM (K132078)Tianjin Walkman Biomaterial Co., Ltd.2014-03-19
VAN HIP FRACTURE SYSTEM (K133104)Epix Orthopaedic, Corp.2014-03-10
CFN-CANNULATED FEMUR NAIL, CTN-CANNULATED TIBIA NAIL, CHN-CANNULATED HUMERAL NAIL (K132945)I.T.S. GmbH2014-03-07
SYNTHES TROCHANTERIC FIXATION NAIL - ADVANCED SYSTEM (K131548)Synthes (USA) Products, LLC2014-02-28
ELLIPSE PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM (K131490)Ellipse Technologies, Inc.2014-01-23
DISTALOCK TIBIAL IM NAIL SYSTEM (K132830)Dgimed Ortho, Inc.2014-01-06
TROCHANTERIC NAILS AND ES TROCHANTERIC NAILS, HUMERAL NAISL, TIBIAL NAILS, ANTEGRADE FEMORAL NAILS, RETROGRADE FEMORAL N (K133081)Advanced Orthopaedic Solutions, Inc.2013-12-31
IDEAL (K132428)Jiangsu Ideal Medical Science & Technology Co., LT2013-12-20
PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM (K133289)Ellipse Technologies, Inc.2013-12-09
AEQUALIS HUMERAL NAIL; SIZES 7MM & 8MM X 210, 230, 250, 270MM; LEFT AND RIGHT (K133376)Tornier, Inc.2013-12-05
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