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OVD

204 FDA 510(k) clearances · Product code

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RecordFirmDate
Arco™-SA Lumbar Cage System (K173082)Neurostructures, Inc.2018-03-29
CASCADIA Interbody System (K172941)K2m2018-02-12
Brisbane ALIF Device, Gladstone ALIF Device (K172019)Signature Orthopaedics Pty, Ltd.2017-11-29
Idys™ ALIF System (K172083)Clariance, Sas2017-11-08
SOVEREIGN™ Spinal System (K172328)Medtronic Sofamor Danek USA, Inc.2017-11-02
INDEPENDENCE® Spacers (K170157)Globus Medical, Inc.2017-09-25
T-Rex Standalone ALIF (K170855)Siats, LLC2017-09-07
IRIX-A Lumbar Integrated Fusion System (K171567)X-Spine Systems, Inc.2017-08-28
Rampart One Lumbar Interbody Fusion Device (K163670)Spineology, Inc.2017-05-08
NuVasive BASE Interfixated Titanium System (K170592)Nu Vasive, Incorporated2017-04-26
Ax Stand-Alone ALIF System (K162236)Innovasis, Inc.2017-04-20
Endoskeleton(R) TAS Interbody Fusion Device / Endoskeleton(R) TAS Hyperlordotic Interbody Fusion Device (K163269)Titan Spine, LLC2017-04-13
MectaLIF Anterior Stand Alone (K170455)Medacta International S.A.2017-03-16
Biomet Fusion System (K163543)Zimmer Biomet Spine, Inc.2017-02-28
SOVEREIGN® Spinal System (K162680)Medtronic Sofamor Danek USA, Inc.2016-12-14
SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion Device (K162351)SeaSpine Orthopedics Corporation2016-12-01
Leva® Anterior Interbody System (K161993)Spine Wave, Inc.2016-11-22
ELSA Spacers (K161379)Globus Medical, Inc.2016-09-29
Avenue® T TLIF Cage (K161173)Ldr Spine USA, Inc.2016-09-28
PILLAR SA PTC (K161129)Orthofix, Inc.2016-09-08
INDEPENDENCE MIS Spacers (K160597)Globus Medical, Inc.2016-08-29
MectaLIF Anterior Stand-Alone (K160605)Medacta International2016-07-21
TransContinental® M Spacers and InterContinental® Plate-Spacers (K161223)Globus Medical, Inc.2016-07-15
ENZA Zero-Profile Anterior Interbody Fusion (K153720)Camber Spine Technologies2016-05-03
NuVasive® Interfixated Interbody System (K160051)Nu Vasive, Incorporated2016-04-20
Optimus ALIF System (K160291)Amendia, Inc.2016-02-18
VerteLP Interbody Fusion Device (K151312)Vgi, LLC2016-01-13
Sahara Stabilization System (K151481)K2m, Inc.2015-12-21
NuVasive Foundation-LL System (K152943)Nu Vasive, Incorporated2015-12-01
SYNFIX Evolution Secured Spacer System (K150673)Synthes (USA) Products, LLC2015-08-21
ALIF Interfixated System (K151214)Nu Vasive, Incorporated2015-06-25
Avenue T TLIF Cage (K142645)Ldr Spine USA, Inc.2015-06-11
Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti (K150643)Centinel Spine, Inc.2015-06-08
Chesapeake Stabilization System (K142487)K2m, Inc.2015-05-07
Ancora LLC Interbody Fusion Device (K143228)Frontier Medical Devices, Inc.2015-02-26
MAGNIFY and MAGNIFY-S Spacers (K142498)Globus Medical, Inc.2015-02-26
SYPHER SPACER SYSTEM (K141798)Biogennix, LLC2015-02-19
AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer, AVS® Navigator PEEK Spacer, AVS® ARIA PEEK Spacer, AccuLIF TL and PL Cage, AVS® Anchor-L Spacer, Aero-AL Lumbar Cage System (K143163)Stryker Corporation2015-01-26
IMPIX ALIF S/A (K141187)Medicrea International SA2015-01-15
Zavation Z-Link Lumbar (K142271)Zavation, LLC2014-12-19
A-LINK Z (K133827)Osteo Vasive, LLC2014-11-17
AERO-LL LUMBAR CAGE SYSTEM (K142066)Stryker Corporation2014-11-13
MIDLINE II TI (K141942)Centinel Spine, Inc.2014-11-07
RENOVIS S134 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM (K142095)Renovis Surgical Technologies, Inc.2014-10-15
BIOMET FUSION SYSTEM (K141791)Biomet Spine2014-10-09
IRIX-A LUMBAR INTEGRATED FUSION SYSTEM (K133947)X-Spine Systems, Inc.2014-07-29
COROENT XL-F SYSTEM (K140479)Nu Vasive, Incorporated2014-07-28
CHESAPEAKE SPINAL SYSTEM (K133494)K2m, Inc.2014-06-10
AERO-AL LUMBAR CAGE SYSTEM (K133328)Stryker Corporation2014-05-30
PROPOSED OPTIMUS (K132596)Custom Spine, Inc.2014-04-11
S128 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM (K140106)Renovis Surgical Technologies, Inc.2014-03-27
MIDLINE (TM) (K133286)Centinel Spine, Inc.2014-01-09
LATERAL SYNFIX (K131276)Synthes (USA) Products, LLC2014-01-06
MONUMENT SPACERS (K132559)Globus Medical, Inc.2013-12-30
COROENT SINGLE TAB SYSTEM (K131723)Nuvasive, Inc.2013-09-20
S128 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM (K131122)Renovis Surgical Technologies, LLC2013-09-18
LOGIC STAND-ALONE INTERVERTEBRAL BODY FUSION DEVICE (K130641)Binder Biomedical, Inc.2013-09-13
STALIF X (K130461)Centinel Spine, Inc.2013-08-28
LANX FUSION SYSTEM (K131547)Lanx, Inc.2013-07-12
MECTALIF ANTERIOR (K124034)Medacta International2013-05-17
VAULT ALIF SYSTEM (K130445)Spinal USA2013-04-25
BRIGADE STANDALONE SYSTEM (K123045)Nuvasive, Inc.2013-04-16
LANX FUSION SYSTEM- SA (K123767)Lanx, Inc.2013-03-18
SOLUS ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM (K123993)Alphatec Spine, Inc.2013-03-05
FRONTIER SADL INTERBODY FUSION DEVICE (K112700)Frontier Medical Devices, Inc.2012-11-01
ANCHOR-L LUMBAR CAGE (K120869)Stryker Spine2012-10-25
VISUALIF CHALLENGING ACCESS PLATE (K122168)Spine Smith Partners L.P.2012-10-11
LDR SPINE USA AVENUE L INTERBODY FUSION (K113285)Ldr Spine USA, Inc.2012-07-26
SOVEREIGN SPINAL SYSTEM (K121982)Medtronic Sofamor Danek2012-07-26
VU APOD INTERVERTEBRAL BODY FUSION DEVICE (K121211)Theken Spine, LLC2012-06-27
INDEPENDENCE SPACER (K120101)Globus Medical, Inc.2012-03-27
SOLITARIE PEEK ANTERIOR SPINAL SYSTEM-TO BE CALLED COLITAIRE 35 (K120557)Biomet Spine & Bone Healing Technologies2012-03-19
CHESAPEAKE SPINAL SYSTEM (K120031)K2m, Inc.2012-03-16
NUVASIVE COROENT NO-PROFILE SYSTEM (K112561)Nuvasive, Inc.2012-03-13
SOVEREIGN SPINAL SYSTEM (K110063)Medtronic Sofamor Danek, Inc.2011-10-04
LDR SPINE ROI-A INTERBODY FUSION SYSTEM (K110327)Ldr Spine USA2011-09-30
ENDOSKELETON(R) TAS (K111626)Titan Spine, LLC2011-09-09
AESCULAP SIBD XP SPINAL SYSTEM (K111122)Aesculap Implant Systems, Inc.2011-08-04
INTERCONTINENTAL PLATE-SPACER (K103382)Globus Medical, Inc.2011-05-20
VAULT ALIF SYSTEM (K103369)Spinal USA2011-04-04
SOLUS ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SPINAL SPACER SYSTEM (K102402)Alphatec Spine, Inc.2011-03-30
LANX FUSION SYSTEM (K102738)Lanx, LLC2011-02-10
ECLIPSE VERTEBRAL SPACER SYSTEM-LUMBAR (K102121)Apollo Spine, Inc.2011-01-12
ANYPLUS PEEK CAGES (K100516)GS Medical Co., Ltd.2010-12-03
SPINESMITH CYNCH SPINAL SYSTEM - VISUALIF INTERBODY FUSION IMPLANT SYSTEM (K102090)Spine Smith Partners L.P.2010-09-30
VU APOD INTERVERTEBRAL BODY FUSION DEVICE (K101310)Theken Spine, LLC2010-09-02
AESCULAP IMPLANT SYSTEMS SIBD SPINAL SYSTEM (K100802)Aesculap Implant Systems, Inc.2010-07-20
COROENT XLR STANDALONE SYSTEM (K100043)Nuvasive, Inc.2010-06-16
INCITE INNOVATION STAND ALONE INTERBODY FUSION DEVICE (K093808)Incite Innovation, LLC2010-03-24
SOLITAIRE AND SOLITAIRE PEEK ANTERIOR SPINAL SYSTEM (K093629)Biomet Spine2010-03-09
CHESAPEAKE SPINAL SYSTEM (K092211)K2m, Inc.2010-03-05
LIFE SPINE STAND-ALONE SPACER SYSTEM (K091301)Life Spine2009-12-15
INTREPID SPINAL SYSTEM (K091813)Medtronic Sofamor Danek2009-11-17
LUCENT MAGNUM (K083475)Spinal Elements, Inc.2009-02-13
ZUMA, MODEL 55-XXXX/56-XXXX (K082926)Seaspine, Inc.2008-12-22
INDEPENDENCE SPACER (K082252)Globus Medical, Inc.2008-11-05
LUCENT MAGNUM+ (K081711)Spinal Elements, Inc.2008-09-11
BLACKSTONE PILLAR SA PARTIAL VERTEBRAL BODY REPLACEMENT DEVICE (K081849)Blackstone Medical, Inc.2008-08-28
SOLITAIRE ANTERIOR SPINAL SYSTEM (K081501)Biomet Spine2008-07-02
VU APOD INTERVERTABRAL BODY FUSION DEVICE (K080822)Theken Spine, LLC2008-07-02
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