Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Orthosis, Spinal Pedicle Fixation

FDA product code MNI · 285 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: 1998-03-20 – 2017-10-12

MNI 2017-10-12

Mikron Spinal Fixation System

Applicant Mikron Makina Sanayi Ticaret Co. , Ltd.

K number K171497

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MNI 2016-10-04

LumFix Spinal Fixation Sytem

Applicant CG Bio Co., Ltd.

K number K160731

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MNI 2016-08-22

Double Medical Universal Spine System

Applicant Double Medical Technology, Inc.

K number K151458

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MNI 2016-06-29

MySpine Pedicle Screw Placement Guides - LP

Applicant Medacta International S.A.

K number K153273

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MNI 2016-04-04

LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System

Applicant Spinevision S.A.

K number K160124

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MNI 2016-04-01

Premier

Applicant Shandong Weigao Orthopaedic Device Co., Ltd.

K number K160320

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MNI 2016-02-26

Sniper (R) Spine System

Applicant Spine Wave, Inc.

K number K160003

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MNI 2016-02-01

YAHUA Spinal System

Applicant Beijing Weigao Yahua Artificial Joint Development Co. , Ltd.

K number K152324

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MNI 2013-12-16

MIKRON SPINAL FIXATION SYSTEM, POLYXIAL PEDICLE SCREWS, SET SCREWS, LONGITUDINAL RODS

Applicant Mikron Makina Sanayi VE Ticaret Ltd. Sti.

K number K130073

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MNI 2013-11-20

EVEREST SPINAL SYSTEM

Applicant K2m, Inc.

K number K132757

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MNI 2013-10-31

ALTUS SPINE PEDICLE SCREW SYSTEM

Applicant Altus Partners

K number K132280

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MNI 2013-10-17

TRUE SPINAL FIXATION SYSTEM

Applicant Innovative Surgical Designs

K number K130958

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MNI 2013-10-10

INERTIA MIS PEDICLE SCREW SYSTEM

Applicant Nexxt Spine, LLC

K number K132412

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MNI 2013-10-03

EVEREST SPINAL SYSTEM

Applicant K2m, Inc.

K number K132361

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MNI 2013-09-19

LOSPA IS PEDICLE SCREW (MONOAXIAL & POLYAXIAL), LOSPA IS ROD- STRAIGHT (STANDARD), LOSPA IS ROD- PRE BENT (STANDARD & BU

Applicant Corentec Co., Ltd.

K number K132644

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MNI 2013-08-20

SPONDYLOLISTHESIS SPINAL FIXATION, SPINAL PEDICLE FIXATION

Applicant Accel Spine

K number K132365

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MNI 2013-08-09

CAPSURE PS SYSTEM

Applicant Spine Wave, Inc.

K number K132154

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MNI 2013-08-09

CORE PEDICLE SCREW SYSTEM

Applicant Core-Nexus

K number K131522

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MNI 2013-07-30

SPINEVISION LUMIS CANNULATED POLYAXIAL PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S. POLYAXIAL PEDICLE SCREW FIXAT

Applicant Spinevision S.A.

K number K130302

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MNI 2013-07-24

REFORM PEDICLE SCREW SYSTEM

Applicant Spinal USA

K number K131343

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MNI 2013-06-20

REFORM PEDICLE SCREW SYSTEM

Applicant Spinal USA

K number K130279

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MNI 2013-02-07

RELIANCE SPINAL SCREW SYSTEM

Applicant Reliance Medical Systems, LLC

K number K123521

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MNI 2012-11-20

S-LOK PSS SYSTEM

Applicant Spinal USA

K number K122931

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MNI 2012-10-31

CERTEX SPINAL IMPLANT SYSTEM

Applicant X-Spine Systems, Inc.

K number K122163

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MNI 2012-10-16

TOWERLOX PEDICLE SCREW SYSTEM

Applicant Captiva Spine

K number K122332

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MNI 2012-10-11

CAPSURE(R) PS SYSTEM

Applicant Spine Wave, Inc.

K number K122233

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MNI 2012-08-15

4CIS VANE SPINE SYSTEM

Applicant Solco Biomedical Co., Ltd.

K number K121615

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MNI 2012-08-08

REFORM PEDICLE SCREW SYSTEM

Applicant Spinal USA

K number K121172

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MNI 2012-06-07

CAPSURE(R) PS SYSTEM

Applicant Spine Wave, Inc.

K number K120646

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MNI 2012-05-25

RANGE SPINAL SYSTEM, UNIT ROD

Applicant K2m, Inc.

K number K120899

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MNI 2012-05-23

LEXUS CERVICAL FIXATION SYSTEM

Applicant L&K BIOMED Co., Ltd.

K number K120879

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MNI 2012-05-18

RANGE SPINAL SYSTEM (MESA AND DENALI)

Applicant K2m, Inc.

K number K120099

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MNI 2012-04-25

SINTEA PLUSTEK PLS MULTI-AXIAL SCREWS

Applicant Sintea Plastek, LLC

K number K112611

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MNI 2012-04-13

CAPLOX II PEDICLE SCREW SYSTEM

Applicant Captiva Spine, Inc.

K number K120292

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MNI 2012-04-04

EVEREST SPINAL SYSTEM

Applicant K2m, Inc.

K number K120656

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MNI 2012-04-02

TIGER SPINE SYSTEM

Applicant Corelink, LLC

K number K120696

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MNI 2012-03-23

PALLS M SPINAL SYSTEM

Applicant Korea Bone Bank Co., Ltd.

K number K120538

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MNI 2012-03-13

AILERON INTERSPINOUS FIXATION SYSTEM

Applicant Life Spine

K number K113157

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MNI 2012-02-01

SAVANNAH TECHNOLOGIES SPINAL SYSTEM

Applicant Savannah Technologies, LLC

K number K113755

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MNI 2012-02-01

SYNTHES USS CONNECTORS

Applicant Synthes Spine

K number K113149

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MNI 2012-01-20

RELIANCE SPINAL SCREW SYSTEM

Applicant Reliance Medical Systems, LLC

K number K110896

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MNI 2011-12-21

RANGE SPINAL SYSTEM (MESA AND DENALI)

Applicant K2m, Inc.

K number K112920

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MNI 2011-11-22

ZAVATION SPINAL SYSTEM

Applicant Zavation, LLC

K number K112484

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MNI 2011-11-21

PASS LP SPINAL SYSTEM

Applicant Medicrea International

K number K112493

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MNI 2011-10-18

SMARTLOC SPINAL FIXATION SYSTEM

Applicant A-Spine Asia, Co., Ltd.

K number K111883

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MNI 2011-10-06

RANGE SPINAL SYSTEM (MESA AND DENALI)

Applicant K2m, Inc.

K number K112037

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MNI 2011-09-13

CAPTIVA SPINE CAPLOX II SPINAL FIXATION SYSTEM

Applicant Captiva Spine, Inc.

K number K111115

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MNI 2011-08-31

CAPSURE(R) PS SYSTEM

Applicant Spine Wave, Inc.

K number K111913

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MNI 2011-08-19

ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM

Applicant Spineart

K number K112108

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MNI 2011-08-11

ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM

Applicant Spineart

K number K111127

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MNI 2011-08-02

MESA SPINAL SYSTEM (KEYSTONE RODS)

Applicant K2m, Inc.

K number K110991

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MNI 2011-07-22

VENUS CERVICAL SPINAL FIXATION SYSTEM

Applicant L&K BIOMED Co., Ltd.

K number K103414

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MNI 2011-07-15

EXACTECH GIBRALT SPINAL SYSTEM

Applicant Exactech, Inc.

K number K110197

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MNI 2011-06-08

NOVEL III SPINAL FIXATION AND ADJUSTABLE BRIDGE SYSTEM

Applicant Medyssey Co, Ltd.

K number K110284

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MNI 2011-05-19

ZENIUS SPINAL SYSTEM

Applicant Medyssey Co, Ltd.

K number K110283

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MNI 2011-03-17

EVEREST SPINAL SYSTEM

Applicant K2m, Inc.

K number K103440

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MNI 2011-02-08

LEUCADIA PEDICLE SCREW SYSTEM

Applicant Phygen, LLC

K number K103102

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MNI 2011-02-02

TALON SPINAL SYSTEM

Applicant Spine360

K number K102995

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MNI 2010-12-29

ZENIUS SPINAL SYSTEM

Applicant Medyssey Co, Ltd.

K number K103272

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MNI 2010-12-16

NOVEL III SPINAL FIXATION AND ADJUSTABLE BRIDGE SYSTEM

Applicant Medyssey Co, Ltd.

K number K103147

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MNI 2010-12-07

S 100 PEDICLE SCREW SYSTEM

Applicant Renovis Surgical Technologies, LLC

K number K101682

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MNI 2010-11-17

MOUNTAINEER OCT SPINAL SYSTEM

Applicant Depuy Spine, Inc.

K number K103100

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MNI 2010-11-05

LIFE SPINE INTERSPINOUS FIXATION SYSTEM

Applicant Life Spine

K number K100407

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MNI 2010-10-15

LDR SPINE USA SPINETUNE TL SPINAL SYSTEM

Applicant Ldr Spine USA

K number K102331

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MNI 2010-10-15

KAPSS SPINAL SYSTEM

Applicant Robert Reid, Inc.

K number K093833

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MNI 2010-08-02

RANGE SPINAL SYSTEM

Applicant K2m, Inc.

K number K100851

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MNI 2010-07-19

FIXPINE II SYSTEM

Applicant Dio Medical Co., Ltd.

K number K100765

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MNI 2010-06-25

MEDYSSEY CO., LTD., ZENIUS SPINAL SYSTEM

Applicant Medyssey Co, Ltd.

K number K093104

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MNI 2010-04-22

DIAMONDBACK SPINAL SYSTEM

Applicant Eminent Spine

K number K100377

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MNI 2010-04-02

AEGIS & AEGIS II SPINAL SYSTEM

Applicant Corentec Co., Ltd.

K number K092076

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MNI 2010-03-31

LDR SPINE USA SPINE TUNE TL SPINE SYSTEM

Applicant Ldr Spine USA

K number K100575

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MNI 2010-03-11

ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM

Applicant Spineart

K number K093936

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MNI 2010-03-04

PASS LP SPINAL SYSTEM

Applicant Medicrea Technologies

K number K100297

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MNI 2010-02-17

ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM

Applicant Alphatec Spine, Inc.

K number K100138

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MNI 2009-12-23

ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM

Applicant Alphatec Spine, Inc.

K number K093077

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MNI 2009-12-10

MODIFICATION TO LANX SPINAL FIXATION SYSTEM

Applicant Lanx, LLC

K number K093285

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MNI 2009-11-19

KRD1 PEDICLE SCREW SYSTEM

Applicant Spinefrontier, Inc.

K number K092420

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MNI 2009-11-06

CASPIAN SPINAL SYSTEM

Applicant K2m, Inc.

K number K092640

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MNI 2009-11-04

ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM

Applicant Spineart

K number K093170

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MNI 2009-09-14

MODIFICATION TO: PSS SYSTEM

Applicant Spinal USA

K number K092128

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MNI 2009-07-31

PASS LP SPINAL SYSTEM

Applicant Medicrea Technologies

K number K083810

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MNI 2009-07-08

ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM

Applicant Alphatec Spine, Inc.

K number K091189

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MNI 2009-07-07

ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM

Applicant Alphatec Spine, Inc.

K number K090779

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MNI 2009-06-30

INERTIA PEDICLE SCREW SYSTEM

Applicant Nexxt Spine, LLC

K number K090984

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MNI 2009-05-06

MODIFICATION TO: PSS SYSTEM

Applicant Spinal USA

K number K090033

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MNI 2009-03-27

THEKEN ATOLL OCT SPINAL SYSTEM

Applicant Theken Spine, LLC

K number K083863

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MNI 2009-03-26

RELIANCE SPINAL SCREW SYSTEM

Applicant Reliance Medical Systems, LLC

K number K081978

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MNI 2009-03-13

THEKEN ATOLL CERVICO-THORACIC SYSTEM

Applicant Theken Spine, LLC

K number K083073

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MNI 2009-02-23

SOLAS ANATOMIX SPINAL SYSTEM

Applicant Biotechni America Spine Group, Inc.

K number K083178

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MNI 2009-01-28

PILOT SPINAL SYSTEM

Applicant Life Spine

K number K083865

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MNI 2009-01-15

TRAUSON GENERAL SPINAL SYSTEM (GSS)

Applicant Trauson (Jiangsu) Medical Instrument Co., Ltd.

K number K082617

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MNI 2009-01-13

CAPSURE PS SYSTEM

Applicant Spine Wave, Inc.

K number K083743

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MNI 2008-12-11

CAPSURE(R) PS SYSTEM

Applicant Spine Wave, Inc.

K number K083353

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MNI 2008-12-10

PASS LP SPINAL SYSTEM

Applicant Medicrea Technologies

K number K083308

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MNI 2008-11-05

MODIFICATION TO 4CIS VANE SPINE SYSTEM

Applicant Solco Biomedical Co., Ltd.

K number K081145

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MNI 2008-10-03

PASS 2 SPINAL SYSTEM

Applicant Medicrea Technologies

K number K082069

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MNI 2008-07-24

MODIFICATION TO SINGLE PLANAR MULTI AXIS (SPMA) PEDICLE SCREW SYSTEM

Applicant Trinity Orthopedics, LLC

K number K081790

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MNI 2008-07-23

COSMIC SYSTEM

Applicant Ulrich GmbH & Co. KG

K number K080841

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MNI 2008-07-03

ZODIC POLYAXIAL SPINAL FIXATION SYSTEM

Applicant Alphatec Spine, Inc.

K number K081158

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MNI 2008-07-02

MODIFICATION TO VERTEBRON PSS PEDICLE SCREW SYSTEM

Applicant Vertebron, Inc.

K number K081597

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