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MAX

895 FDA 510(k) clearances · Product code

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RecordFirmDateBuilder
Reliance Lumbar IBF System (K160463)Reliance Medical Systems, LLC2016-05-20+ Add
Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine VEO™ Lateral Access & Interbody Fusion System, Choice Spine Interbody Fusion System (K153107)Choicespine, LP2016-05-19+ Add
NeoFuse HA Enhanced PLIF/TLIF (K153615)Ht Medical, LLC2016-05-06+ Add
SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIF (K153783)Spinevision S.A.2016-05-04+ Add
Genesys Spine Apache Interbody Fusion System (K153123)Genesys Spine2016-04-26+ Add
Leva Spacer System (K153222)Spine Wave, Inc.2016-04-15+ Add
NuVasive CoRoent Thoracolumbar System (K153419)Nu Vasive, Incorporated2016-04-13+ Add
SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers, INDEPENDENCE TPS Spacer, FORTIFY -R TPS Corpectomy Spacer, FORTIFY I-R TPS Corpectomy Spacer, XPand -R TPS Corpectomy Spacer, NIKO TPS Corpectomy Spacer (K143578)Globus Medical, Inc.2016-04-13+ Add
Opticage(R) Expandable Interbody Fusion Device (K160464)Interventional Spine, Inc.2016-04-04+ Add
Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T Implant System (K153495)Ldr Spine USA2016-03-31+ Add
SurgTech Interbody System (K152200)Surgtech, Inc.2016-03-25+ Add
NuVasive® Lumbar Interbody Implants (K153782)Nu Vasive, Incorporated2016-03-24+ Add
Cascadia Interbody System (K160547)K2m2016-03-24+ Add
NuVasive® TLX Interbody System (K153627)Nu Vasive, Incorporated2016-03-17+ Add
SUSTAIN Additional Implants (K151665)Globus Medical, Inc.2016-03-16+ Add
ProLift Expandable System (K153400)Life Spine, Inc.2016-03-07+ Add
PERIMETER Interbody Fusion Device (K160418)Medtronic Sofamor Danek USA, Inc.2016-03-07+ Add
Cogent Lateral Interbody System (K151406)Cogent Spine, LLC2016-02-25+ Add
SpineView X-Pac Expandable Lumbar Cage System (K152539)Spine View, Inc.2016-02-24+ Add
Rampart A Lumbar Interbody Fusion Device (K153082)Spineology, Inc.2016-02-04+ Add
Half Dome Posterior Lumbar Interbody System (K152512)Astura Medical2016-01-28+ Add
Biomet Spine Fusion System (K153695)Biomet Spine, LLC2016-01-21+ Add
AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS TL PEEK Spacer, AVS Navigator PEEK Spacer, AVS ARIA PEEK Spacer (K151726)Stryker Corporation2016-01-20+ Add
Spine Wave Gen II Expandable Interbody System (K152620)Spine Wave, Inc.2016-01-15+ Add
Spine Innovation Interbody System (K153356)Spine Innovation, LLC2016-01-14+ Add
FORZA PTC Spacer System (K152475)Orthofix, Inc.2016-01-14+ Add
Amendia Interbody Fusion Devices (K151310)Amendia, Inc.2016-01-06+ Add
AccuLIF TL and PL Cage (K152651)Stryker Corporation2015-12-15+ Add
VariLift-L Interbody Fusion Device (K151900)Wenzel Spine, Inc.2015-12-11+ Add
Twin Peaks Lumbar Interbody Fusion System (K152355)Spineway2015-12-10+ Add
CONCORDE Bullet Lumbar Interbody System (K151773)Medos International SARL2015-11-20+ Add
Tritanium PL Cage (K152304)Stryker2015-11-19+ Add
InFill Interbody Fusion Device (K152259)Pinnacle Spine Group, LLC2015-11-19+ Add
PIVOX(tm) Oblique Lateral Spinal System (K152277)Medtronic Sofamor Danek USA, Inc.2015-11-13+ Add
Integrity Spine Lumbar Interbody Fusion System (K151819)Integrity Spine Lumbar Interbody Fusion System2015-11-10+ Add
Opticage Expandable Interbody Fusion Device (K152156)Interventional Spine, Inc.2015-10-19+ Add
Px HA PEEK IBF System (K151785)Innovasis, Inc.2015-10-14+ Add
CONCORDE Bullet Spinal System (K151352)Medos International SARL2015-10-08+ Add
Valeo Spacer System and Valeo II Interbody Fusion Device System (K143518)Amedica Corp.2015-10-02+ Add
LOSPA IS Spinal System (K151408)Corentec Co., Ltd.2015-10-02+ Add
Bluefin Interbody System (K143479)Tides Medical2015-09-25+ Add
Amendia Interbody Fusion Devices (K151322)Amendia, Inc.2015-09-10+ Add
NuVasive CoRoent Lumbar System (K151472)Nu Vasive, Incorporated2015-09-10+ Add
STERISPINE LC CAGE (K151756)Safe Orthopaedics2015-08-21+ Add
Cascadia Interbody System (K150481)K2m, Inc.2015-08-20+ Add
LnK Lumbar Interbody Fusion Cage System (K151140)L&K BIOMED Co., Ltd.2015-08-18+ Add
Aesculap T-Space PEEK and XP Spinal System (K151056)Aesculap Implant Systems, LLC2015-08-13+ Add
Omega LIF System (K150395)Amendia, Inc.2015-08-10+ Add
NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, NuVasive AP Expandable XLIF System (K151374)Nu Vasive, Incorporated2015-08-06+ Add
CAPSTONE Spinal System, CLYDESDALE Spinal System (K151128)Medtronic Sofamor Danek USA, Inc.2015-08-06+ Add
Biomet Spine Fusion System (K151483)Biomet Spine, LLC2015-07-31+ Add
PATHWAY ELIF (K143143)Custom Spine, Inc.2015-07-22+ Add
Rampart-T Interbody Fusion System (K151020)Spineology, Inc.2015-07-22+ Add
PROW FUSION (K151654)Nlt Spine, Ltd.2015-07-17+ Add
InFill Interbody Fusion Devices (K151184)Pinnacle Spine Group, LLC2015-07-14+ Add
EVOS Lumbar Interbody System (K150321)Cutting Edge Spine, LLC2015-07-13+ Add
EndoLIF On-Cage (K151143)Joimax GmbH2015-07-09+ Add
Leva Spacer System (K151581)Spine Wave, Inc.2015-07-09+ Add
Px PEEK IBF System (K150500)Innovasis, Inc.2015-06-19+ Add
DePuy Synthes T-PAL Ti Spacer (K151276)Synthes USA Products, LLC2015-06-18+ Add
DIVERGENCE-L Anterior/Oblique Lumbar Fusion System (K150135)Medtronic Sofamor Danek USA, Inc.2015-06-11+ Add
ELEVATE Spinal System (K142559)Medtronic Sofamor Danek USA, Inc.2015-06-09+ Add
Battalion Universal Spacer System (K143740)Alphatec Spine, Inc.2015-05-22+ Add
Lucent; Lucent Ti-Bond Systems (K150061)Spinal Elements, Inc.2015-05-19+ Add
SpineFrontier Lumbar Interbody Fusion Device System (K142504)Spinefrontier, Inc.2015-05-13+ Add
The Octane Straight Intervertebral Fusion Device, Ti Coated (K150152)Exactech, Inc.2015-05-11+ Add
Elite L Expandable Lumbar Fusion System (K150954)Innova Spinal Technologies, LLC2015-05-07+ Add
NuVasive(R) CCX-L Interbody System (K143595)Nu Vasive, Incorporated2015-04-29+ Add
Zavation Posterior LEIF (K142392)Zavation, LLC2015-04-29+ Add
INTERBODY CAGE (K140348)Eisertech, LLC2015-04-23+ Add
PLIF STS, TLIF STS, OLIF STS (Spinal Truss System) (K143258)4Web, Inc.2015-04-09+ Add
InFill Interbody Fusion Devices (K150206)Pinnacle Spine Group, LLC2015-04-03+ Add
Xenco Medical Lumbar Interbody System (K143158)Xenco Medical, LLC2015-03-20+ Add
NuVasive CoRoent System (K141665)Nuvasive, Inc.2015-03-13+ Add
Biomet Spine Fusion System (K142634)Biomet Spine, LLC2015-03-12+ Add
Leva(TM) Spacer System (K150285)Spine Wave, Inc.2015-03-05+ Add
AccuLIF TL and PL Cage (K143616)Stryker Corporation2015-03-05+ Add
Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody Fusion System, InFix Anterior Lumbar System, TraXis Vertebral Body Replacement (Ti and VUE) (K143297)Zimmer Spine, Inc.2015-02-12+ Add
Renovis S141 Lumbar Interbody Cage System (K143126)Renovis Surgical Technologies2015-02-06+ Add
LEVA (TM) SPACER SYSTEM (K141980)Spine Wave, Inc.2015-01-26+ Add
SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura) NanoMetalene, Cambria NanoMetalene , Vu aPOD-L NanoMetalene, Vu ePOD NanoMetalene (K142488)Seaspine, Inc.2014-12-18+ Add
JULIET LL (K141135)Spineart2014-12-01+ Add
nva, nvp, nvt (K142594)Nvision Biomedical Technologies, LLC2014-11-28+ Add
OPTICAGE EXPANDABLE INTERBODY FUSION DEVICE (K140716)Interventional Spine, Inc.2014-11-24+ Add
LUNA INTERBODY SYSTEM (K142023)Benvenue Medical, Inc.2014-11-20+ Add
COROENT SYSTEM (K141896)Nu Vasive, Incorporated2014-11-20+ Add
Amedica Valeo II Interbody Fusion Device (K142347)Amedica Corp.2014-11-18+ Add
ENDOSKELETON; TA IBD AND VBR, TO AND TT, TAS, TC, TL (K141953)Titan Spine, LLC2014-10-27+ Add
ABACUS (TM) SPACER SYSTEM (K142101)Spine Wave, Inc.2014-10-23+ Add
Endoskeleton TA IBD and VBR, Endoskeleton TO and TT, Endoskeleton TAS, Endoskeleton TAS, Endoskeleton TC, Endoskeleton TL (K142589)Titan Spine, LLC2014-10-17+ Add
COGENT MED-LIF XL (K142193)Cogent Spine, LLC2014-10-15+ Add
JULIET PO (K142277)Spineart2014-10-14+ Add
COROENT TI-C SYSTEM (K140319)Nuvasive, Inc.2014-10-09+ Add
INNESIS PEEK TL CAGE (K140577)Bk Meditech, Co., Ltd.2014-10-01+ Add
CLYDESDALE(R) SPINAL SYSTEM (K133577)Medtronic Sofamor Danek USA, Inc.2014-09-26+ Add
4WEB SPINAL IMPLANT PRODUCTS (K142112)4Web, Inc.2014-09-23+ Add
LONGBOW SPACER SYSTEM (K133717)Life Spine2014-09-19+ Add
MOBIS II ST SPINAL IMPLANT (K141405)Signus Medizintechnik GmbH2014-09-16+ Add
INFRONT LUMBAR INTERBODY FUSION SYSTEM (K141443)Infront Medical, LLC2014-08-28+ Add
MLX - MEDIAL LATERAL EXPANDABLE LUMBAR INTERBODY SYSTEM (K140770)Nu Vasive, Incorporated2014-07-25+ Add
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