Orthosis, Spondylolisthesis Spinal Fixation

FDA product code MNH · 287 cleared devices

Class 2 Orthopedic

Regulation: 21 CFR 888.3070
Review panel: OR
Implant: Yes
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1995-01-20 – 2016-12-02

MNH 2016-12-02

Reliance Spinal Screw System

Applicant Reliance Medical Systems, LLC

K number K162066

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MNH 2016-11-03

CastleLoc Spinal Fixation System

Applicant L&K BIOMED Co., Ltd.

K number K162801

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MNH 2016-09-23

FixxSure® X-Link

Applicant Innovasis, Inc.

K number K162143

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MNH 2016-09-21

Spinal fixation system

Applicant Canwell Medical Co., Ltd.

K number K161151

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MNH 2016-08-30

ANAX™ 5.5 Spinal System

Applicant U&I Corporation

K number K162189

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MNH 2016-05-05

HC Spinal System

Applicant Hung Chun Bio-S Co., Ltd.

K number K151362

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MNH 2016-04-21

Zavation Spinal System

Applicant Zavation, LLC

K number K153404

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MNH 2016-03-02

Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System

Applicant Captiva Spine

K number K160020

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MNH 2013-12-17

PERFIX ILIAC SCREW SYSTEM

Applicant U&I Corporation

K number K132218

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MNH 2013-11-25

ANAX 5.5 SPINAL SYSTEM

Applicant U&I Corporation

K number K132101

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MNH 2013-08-08

OSSEUS BLACK DIAMOND PEDICLE SCREW SYSTEM

Applicant Osseus Fusion Systems, LLC

K number K131810

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MNH 2013-08-08

CAPLOX II PEDICLE SCREW SYSTEM/TOWERLOX PEDICLE SCREW SYSTEM

Applicant Captiva Spine

K number K131538

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MNH 2013-05-31

ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM

Applicant Spineart

K number K130267

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MNH 2013-04-12

INTRAMEDULLARY NAIL SYSTEM

Applicant Weigao Orthopaedic Device Co., Ltd.

K number K122994

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MNH 2013-03-11

GSO GS1 CANNULATED SCREW SYSTEM

Applicant Gold Standard Orthopaedics, LLC

K number K123487

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MNH 2013-02-15

SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM

Applicant Spinefrontier, Inc.

K number K123164

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MNH 2013-01-08

MEGA 5.5 SPINE SYSTEM

Applicant Lsk Biopartners, Inc.

K number K123476

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MNH 2013-01-04

INSTINCT JAVA SYSTEM

Applicant Zimmer Spine

K number K122592

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MNH 2012-12-03

GALLEON PEDICLE SCREW SYSTEM

Applicant Everest Spine, LLC

K number K122814

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MNH 2012-10-23

FORTEX PEDICLE SCREW SYSTEM

Applicant X-Spine Systems, Inc.

K number K120832

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MNH 2012-06-27

RANGE SPINAL SYSTEM (MESA AND DENALI)

Applicant K2m, Inc.

K number K121016

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MNH 2012-06-27

LDR SPINE SPINETUNE TL SPINAL SYSTEM

Applicant Ldr Spine USA, Inc.

K number K120760

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MNH 2012-05-15

S 100 PEDICLE SCREW SYSTEM

Applicant Renovis Surgical Technologies, LLC

K number K111940

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MNH 2012-05-09

DSS STABILIZATION SYSTEM-RIGID

Applicant Paradigm Spine, LLC

K number K120491

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MNH 2012-05-09

SYNSTER PEDICLE SCREW SYSTEM SYNSTER PLUS PEDICLE SCREW SYSTEM

Applicant Bm Korea Co., Ltd.

K number K120353

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MNH 2011-12-28

ARTS2 SPINAL FIXATION SYSTEM

Applicant Advanced Medical Technologies

K number K103573

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MNH 2011-12-15

LANCER PEDICLE SCREW SYSTEM

Applicant Spinal Solutions, LLC

K number K110633

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MNH 2011-12-12

XINGTM SPINE SYSTEM

Applicant Implanova Co., Ltd.

K number K111995

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MNH 2011-11-22

DEVINE SPINAL SYSTEM

Applicant Changzhou Orthmed Medical Instrument Co., Ltd.

K number K111690

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MNH 2011-09-26

PASS LP SPINAL SYSTEM

Applicant Medicrea International

K number K110497

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MNH 2011-09-21

ODALYS PEDICLE SCREW SYSTEM

Applicant Kalitec Direct, LLC

K number K111370

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MNH 2011-07-21

REXIOUS SPINAL FIXATION SYSTEM

Applicant Dio Medical Co., Ltd.

K number K111362

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MNH 2011-06-13

4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM

Applicant Solco Biomedical Co., Ltd.

K number K102458

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MNH 2011-05-25

TIGER SPINE SYSTEM

Applicant Corelink, LLC

K number K110321

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MNH 2011-03-16

AAXTER A3 POSTERIOR SPINAL SYSTEM

Applicant Aaxter Co., Ltd.

K number K101374

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MNH 2011-03-07

PALLA M SPINAL SYSTEM

Applicant Korea Bone Bank Co., Ltd.

K number K102574

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MNH 2011-03-03

ZENITH PEDICLE SYSTEM

Applicant Apollo Spine, Inc.

K number K102636

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MNH 2011-02-11

4CIS VANE SPINE SYSTEM

Applicant Solco Biomedical Co., Ltd.

K number K101818

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MNH 2011-02-09

VENUS BASIC SPINAL FIXATION SYSTEM

Applicant L&K BIOMED Co., Ltd.

K number K103085

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MNH 2011-01-25

FLAMENCO SPINAL FIXATION SYSTEM

Applicant Ulrich GmbH & Co. KG

K number K102853

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MNH 2011-01-21

EXACTECH PROLIANT POLYAXIAL PEDICLE SCREW SYSTEM

Applicant Exactech, Inc.

K number K102870

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MNH 2011-01-20

EMERALD SPINAL SYSTEM

Applicant Mazor Surgical Technologies , Ltd.

K number K101446

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MNH 2010-12-20

INERTIA PEDICLE SCREW SYSTEM

Applicant Nexxt Spine, LLC

K number K101278

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MNH 2010-12-10

APEX SPINE SYSTEM W/ COCR RODS

Applicant Spinecraft, LLC

K number K102488

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MNH 2010-08-10

QUANTUM/STREAMLINE TL MIS SPINAL SYSTEM

Applicant Pioneer Surgical Technology

K number K093771

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MNH 2010-07-28

ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM

Applicant Spineart

K number K101678

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MNH 2010-07-22

VENUS BASIC SPINAL FIXATION SYSTEM

Applicant L&K BIOMED Co., Ltd.

K number K100706

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MNH 2010-07-09

SPONDY SPINAL FIXATION SYSTEM

Applicant Allure Spine LLC

K number K100956

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MNH 2010-06-30

TYCHE PEDICLE SCREW SYSTEM

Applicant Kyung Won Medical Co., Ltd.

K number K100373

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MNH 2010-06-04

MIS SYSTEM

Applicant Spine Wave, Inc.

K number K100605

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MNH 2010-03-18

MODIFICATION TO: OASYS SYSTEM

Applicant Stryker Spine

K number K093670

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MNH 2010-02-12

MODIFICATION TO CAPSURE PS SYSTEM

Applicant Spine Wave, Inc.

K number K100122

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MNH 2009-11-09

PERFIX SPINAL SYSTEM, MODEL SNA4530-9610, SNM4530-9610, SN3020 (TOTAL: 549)

Applicant U&I Corp.

K number K091725

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MNH 2009-10-28

NORM SPINAL SYSTEM

Applicant Norm Tibbi Urunler Ithalat Ihracat Sanayi VE Ticar

K number K092011

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MNH 2009-10-26

ULC SPINAL PEDICLE SCREW SYSTEM

Applicant Otis Biotech Co., Ltd.

K number K083077

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MNH 2009-09-14

GII SPINAL FIXATION SYSTEM, GII-TI-POLY AXIAL SCREW

Applicant Co-Ligne AG

K number K083567

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MNH 2009-07-30

FORTEX PEDICLE SCREW SYSTEM

Applicant X-Spine Systems, Inc.

K number K090224

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MNH 2009-07-27

ALPINE PEDICLE SCREW SYSTEM

Applicant Sanacor

K number K090477

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MNH 2009-07-24

SPINAL EDGE TITAN PEDICLE SCREW SYSTEM

Applicant Spinal Edge, LLC

K number K091110

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MNH 2009-05-14

DVX SPINE SYSTEM

Applicant Bk Meditech, Co., Ltd.

K number K090424

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MNH 2009-04-29

ROC LUMBAR PLATING SYSTEM

Applicant Alphatec Spine, Inc.

K number K090228

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MNH 2009-04-07

LANX SPINAL FIXATION SYSTEM

Applicant Lanx, Inc.

K number K083581

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MNH 2009-03-04

MESA SPINAL SYSTEM

Applicant K2m, Inc.

K number K080611

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MNH 2009-01-30

NOVEL SPINAL SYSTEM

Applicant Medyssey Co, Ltd.

K number K081153

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MNH 2009-01-22

LAGUNA POLYAXIAL PEDICLE SCREW SYSTEM

Applicant Allez Spine, LLC

K number K083826

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MNH 2008-12-17

ELLIPSE LUMBAR POSTERIOR OSTEOSYNTHESIS SYSTEM

Applicant Spineart

K number K081165

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MNH 2008-12-15

EOS SPINAL SYSTEM

Applicant Korea Bone Bank Co., Ltd.

K number K082509

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MNH 2008-10-03

PASS LP SPINAL SYSTEM

Applicant Medicrea Technologies

K number K082577

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MNH 2008-09-24

MODIFICATION TO PREFERENCE PEDICLE SCREW SYSTEM

Applicant Us Spine

K number K081883

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MNH 2008-09-23

4CIS SOLAR AND APOLLON SPINE SYSTEMS

Applicant Solco Biomedical Co., Ltd.

K number K082453

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MNH 2008-07-23

FIXXSURE CROSS LINK

Applicant Spineworks, LLC

K number K081331

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MNH 2008-07-18

SINTEA BIOTECH PLS MULTI-AXIAL SCREWS

Applicant Sintea Biotech, Inc.

K number K081631

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MNH 2008-06-27

GPS, G SURGICAL PEDICLE SYSTEM

Applicant G Surgical Co., Ltd.

K number K081041

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MNH 2008-06-27

MOUNTAINEER OCT SPINAL SYSTEM

Applicant Depuy Spine, Inc.

K number K080828

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MNH 2008-06-13

RANGE SPINAL SYSTEM, LARGE DENALI SCREWS

Applicant K2m, Inc.

K number K081381

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MNH 2008-06-06

PREFERENCE PEDICLE SCREW SYSTEM

Applicant Us Spine

K number K081296

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MNH 2008-06-04

DVX SPINE SYSTEM

Applicant Bk Meditech, Co., Ltd.

K number K080876

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MNH 2008-02-04

ACCIN PEDICLE SCREW SYSTEM

Applicant Accelerated Innovation, LLC

K number K073531

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MNH 2007-11-09

ZODIAC 4.0 POLYAXIAL SPINAL FIXATION SYSTEM

Applicant Alphatec Spine, Inc.

K number K071890

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MNH 2007-10-18

MODIFICATION TO PASSMED SPINAL SYSTEM

Applicant Medicrea Technologies

K number K070530

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MNH 2007-09-14

CAPLESS LI PEDICLE SCREW SYSTEM

Applicant X-Spine Systems, Inc.

K number K072282

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MNH 2007-06-13

LOWTOP PEDICLE SCREW SYSTEM

Applicant Sanacor

K number K070933

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MNH 2007-01-12

VERTIFLEX SPINAL SCREW SYSTEM

Applicant Vertiflex (Tm), Incorporated

K number K062670

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MNH 2006-11-02

MODIFICATION TO EXPEDIUM SPINE SYSTEM

Applicant Depuy Spine, Inc.

K number K062174

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MNH 2006-09-26

ISS INTEGRATED SPINE SYSTEM

Applicant Ortho Development Corp.

K number K061524

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MNH 2006-09-19

MANTIS SPINAL SYSTEM

Applicant Stryker Spine

K number K061813

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MNH 2006-09-14

OVALTWIST PEDICLE SCREW SYSTEM

Applicant Signus Medizintechnik GmbH

K number K061577

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MNH 2006-09-11

SFX SNAP-FIT CROSS CONNECTOR

Applicant Depuy Spine, Inc.

K number K062196

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MNH 2006-09-05

PILOT POSTERIOR LUMBAR PLATING SYSTEM

Applicant Life Spine

K number K061364

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MNH 2006-09-01

MODIFICATION TO NUVASIVE SPHERX II SYSTEM

Applicant Nuvasive, Inc.

K number K062317

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MNH 2006-07-26

BAR PEDICLE SCREW SPINAL FIXATION SYSTEM, MODEL 2020

Applicant Applied Spine Technologies, Inc.

K number K061162

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MNH 2006-07-25

CD HORIZON SPINAL SYSTEM

Applicant Medtronic Sofamor Danek

K number K061915

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MNH 2006-07-25

EBI 5.5 HELICAL FLANGE SPINAL SYSTEM

Applicant Ebi, L.P.

K number K061441

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MNH 2006-07-18

NUVASIVE SPHERX II SYSTEM

Applicant Nuvasive, Inc.

K number K061778

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MNH 2006-07-12

NFIX FUSION SYSTEM

Applicant N-Spine, Inc.

K number K053623

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MNH 2006-07-07

ZODIAC ADJUSTABLE BRIDGES, MODELS 11-20XX,11-25XX,11-30XX,11-35XX

Applicant Alphatec Spine, Inc.

K number K061321

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MNH 2006-06-22

4CIS VANE SPINE SYSTEM

Applicant Solco Biomedical Co., Ltd.

K number K060702

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MNH 2006-06-08

SSP PEDICLE SCREW SYSTEM

Applicant Specialty Spine Products, LLC

K number K060118

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MNH 2006-04-12

NUVASIVE SPHERX SYSTEM

Applicant Nuvasive, Inc.

K number K060225

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MNH 2006-03-08

GSS PEDICLE SCREW SYSTEM

Applicant GS Medical Co., Ltd.

K number K053573

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