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MAX

895 FDA 510(k) clearances · Product code

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RecordFirmDateBuilder
Lucent® (K170235)Spinal Elements, Inc.2017-11-29+ Add
Arlington PLIF/TLIF Cage (K172020)Signature Orthopaedics Pty, Ltd.2017-11-29+ Add
IMPIX 3D Print Cages (K163595)Medicrea International SA2017-11-13+ Add
Lateral Spinal Truss System (LSTS) Interbody Fusion Device (K172392)4Web, Inc.2017-11-07+ Add
Medussa-PL Cage (K170341)Medyssey USA, Inc.2017-11-02+ Add
IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF) (K173080)Huvexel Co. , Ltd.2017-10-31+ Add
NuVasive® Modulus TLIF Interbody System (K172341)Nu Vasive, Incorporated2017-10-26+ Add
SeaSpine Ventura NanoMetalene System (K173022)SeaSpine Orthopedics Corporation2017-10-26+ Add
Cortina™ Lumbar Cage System (K171914)Neurostructures, Inc.2017-10-25+ Add
Ortus™ Expandable Lumbar Interbody Fusion System (K172334)Atlas Spine, Inc.2017-10-25+ Add
Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D Technology (K172343)Rti Surgical, Inc.2017-10-23+ Add
NuVasive® Modulus XLIF Interbody System (K172123)Nu Vasive, Incorporated2017-10-11+ Add
ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with TiONIC Technology (K171689)Medtronic Sofamor Danek USA, Inc.2017-10-05+ Add
Calix Lumbar Spinal Implant System (K170119)X-Spine Systems, Inc.2017-09-29+ Add
NuVasive TLX Interbody System (K171633)Nu Vasive, Incorporated2017-09-28+ Add
CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal System (K171107)Medtronic Sofamor Danek USA, Inc.2017-09-26+ Add
ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium (K172199)Medtronic Sofamor Danek2017-09-19+ Add
FLXfit™ (K171519)Expanding Orthopedics, Inc.2017-09-15+ Add
Ti-Diagon Oblique TLIF (K172064)Camber Spine Technologies2017-09-15+ Add
Posterior Spine Truss System (PSTS) Interbody Fusion Device (K171351)4Web, Inc.2017-09-08+ Add
Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone Synergy Cervical Interbody Fusion System (Slate) (K171893)Bluestone Synergy2017-09-08+ Add
Altus Spine Titanium Interbody Fusion System (K171329)Altus Partners, LLC2017-08-29+ Add
Duo Lumbar Interbody Fusion Device (K171660)Spineology, Inc.2017-08-18+ Add
ShurFit 2C Lumbar Interbody Fusion System (K171657)Precision Spine, Inc.2017-08-11+ Add
Renovis S141 Lumbar Interbody Fusion System (K170888)Renovis Surgical Technologies2017-08-08+ Add
Anterior Spine Truss System (STS) Interbody Fusion Device (K170851)4Web, Inc.2017-08-07+ Add
The TiBow Expandable Spacer System (K170919)Life Spine, Inc.2017-08-03+ Add
LumFuse-TP (K171630)Precifit Medical, Ltd.2017-07-25+ Add
Rampart L Lumbar Interbody Fusion Device (K171724)Spineology, Inc.2017-07-24+ Add
CONCORDE LIFT (K171425)Medos International SARL2017-07-20+ Add
HD Lumbar Interbody System (K170676)Hd Lifesciences, LLC2017-07-13+ Add
Genesys Spine Apache Interbody Fusion System (K171656)Genesys Spine2017-07-13+ Add
EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular Titanium TLIF Cages, and EIT Cellular Titanium ALIF Cages (K170503)Eit Emerging Implant Technologies GmbH2017-07-11+ Add
Endoskeleton TO Interbody Fusion Device (IBD) (K170399)Titan Spine, LLC2017-07-06+ Add
CRESCENT™ Spinal System (K171031)Medtronic Sofamor Danek2017-07-06+ Add
SAGICO IBF SYSTEM – ARIA LUMBAR, SAGICO IBF SYSTEM – ARION CERVICAL (K161710)Spinal Analytics & Geometrical Impant Co, LLC2017-06-29+ Add
Tranquil Interbody System (K170297)Nexus Spine, LLC2017-06-27+ Add
NuVasive® CoRoent® Thoracolumbar System (K170962)Nu Vasive, Incorporated2017-06-26+ Add
Coalesce™ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar Interbody Fusion System (K163506)Vertera, Inc.2017-06-19+ Add
FUSE Spinal System (K171468)Medtronic Sofamor Danek2017-06-13+ Add
SPIRA Open Matrix ALIF (K162986)Camber Spine Technologies2017-06-12+ Add
TELIX K Interbody System (K170890)Biedermann Motech GmbH & Co. KG2017-06-02+ Add
Talos® Lumbar (HA) PEEK IBF Devices (K170395)Meditech Spine, LLC2017-06-02+ Add
DIVERGENCE-L ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM (K162212)Medtronic Sofamor Danek USA, Inc.2017-05-19+ Add
MOJAVE Expandable Interbody System (K171097)K2m, Inc.2017-05-10+ Add
HALF DOME Posterior Lumbar Interbody System (K163481)Astura Medical2017-05-03+ Add
NuVasive CoRoent Ti-C System (K163707)Nu Vasive, Incorporated2017-05-01+ Add
Summit Spine Yellowstone Lumbar Interbody Fusion System (K170572)Summit Spine2017-04-26+ Add
NeoFuse HA Enhanced PLIF/TLIF (K170511)Ht Medical, LLC2017-04-25+ Add
Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) System (K170643)Rti Surgical, Inc. Dba Rti Biologics2017-04-14+ Add
Keos Lumbar IBFD (K163386)Keos2017-04-10+ Add
Leva Anterior Expandable Spacer System (K163246)Spine Wave, Inc.2017-04-06+ Add
Zavation IBF (K162206)Zavation, LLC2017-04-04+ Add
LOSPA IS TLIF & DLIF Cages (K170243)Corentec Co., Ltd.2017-03-31+ Add
VertebraLINK Fusion Platform (K162693)Facetlink Dba Linkspine2017-03-29+ Add
NuVasive Modulus XLIF Interbody System (K163230)Nu Vasive, Incorporated2017-03-16+ Add
MOJAVE Expandable Interbody System (K163364)K2m2017-03-15+ Add
Altus Spine Titanium Interbody Fusion System (K170512)Altus Partners, LLC2017-03-10+ Add
Rampart(TM) T Lumbar Interbody Fusion Device (K163409)Spineology, Inc.2017-03-08+ Add
SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION® Spacers, COALITION AGX™ Spacers, INDEPENDENCE® Spacers, FORTIFY®-R Corpectomy Spacers, FORTIFY® I-R Corpectomy Spacers, XPand®-R Corpectomy Spacers, NIKO® Corpectomy Spacers, MONUMENT™ Spacers, ALTERA™ Spacers, MAGNIFY™ Spacers, InterContinental® Plate-Spacer (K152022)Globus Medical, Inc.2017-02-22+ Add
Atlas Spine Expandable Interbody System (K162918)Atlas Spine, Inc.2017-02-09+ Add
Elite Expandable Interbody Fusion Device (K162879)Spineology, Inc.2017-01-30+ Add
Altus Spine Interbody Fusion System (K160976)Altus Partners, LLC2017-01-25+ Add
Hubble II (K163180)Orbbo Surgical, LLC2016-12-29+ Add
FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK Lateral Interbody Fusion System (K162446)Orthofix, Inc.2016-12-22+ Add
COUGAR® LS Lateral Cage System and COUGAR® System (K162327)Medos International SARL2016-12-12+ Add
Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine Interbody Fusion System (Harrier™), Choice Spine Vertebral Body Replacement System (Hawkeye™) (K162103)Choicespine, LP2016-11-23+ Add
Xsert Lumbar Expandable Interbody System (K160959)X-Spine Systems, Inc.2016-11-17+ Add
Luna 3D Interbody Fusion System (K162431)Benvenue Medical, Inc.2016-11-17+ Add
Lumbar Interbody Fusion System (ALIF, PLIF, LLIF, TPLIF) (K160663)Evolution Spine, LLC2016-11-16+ Add
Tritanium® PL Cage (K162262)Stryker2016-11-09+ Add
Amendia Interbody Fusion Devices (K160924)Amendia, Inc.2016-11-08+ Add
Genesys Spine Apache® Anterior Lumbar Interbody Fusion System (K161438)Genesys Spine2016-11-08+ Add
T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System (K162358)Synthes USA Products, LLC2016-11-01+ Add
SeaSpine Spacer System- Hollywood NanoMetalene, Hollywood VI NanoMetalene, Ventura NanoMetalene; SeaSpine Cambria NanoMetalene (K162715)SeaSpine Orthopedics Corporation2016-10-28+ Add
Rampart D Lumbar Interbody Fusion Device (K160074)Spineology, Inc.2016-10-18+ Add
XCage™ Interbody Fusion System (K160076)Ouroboros Medical, Inc.2016-10-13+ Add
nva, nvp, and nvt (K162426)Nvision Biomedical Technologies, LLC2016-09-29+ Add
Cascadia Interbody System (K162264)K2m, Inc.2016-09-21+ Add
PROW FUSION-L (K153665)Nlt Spine, Ltd.2016-09-15+ Add
JULIET® LL Lateral Lumbar Cage (K161888)Spineart2016-09-12+ Add
Nanovis Intervertebral Body Fusion System and Forticore(R) (K161485)Nanovis, LLC2016-09-06+ Add
NuVasive Lumbar Interbody Implants (K161230)Nu Vasive, Incorporated2016-08-25+ Add
XYcor® Expandable Spinal Spacer System (K160646)Alphatec Spine, Inc.2016-08-24+ Add
Valeo II Interbody Fusion Device System (K161405)Amedica Corp.2016-08-19+ Add
SpineView X-Pac Expandable Lumbar Cage System (K160856)Spine View, Inc.2016-08-01+ Add
VIRTU Lumbar Spacer System (K160699)Met 1 Technologies, LLC2016-08-01+ Add
Tritanium® PL Cage (K160955)Stryker2016-07-21+ Add
Genesys Spine Apache® Lateral Lumbar Interbody Fusion System (K161404)Genesys Spine2016-07-21+ Add
Keos Lumbar IBFD (K160631)Keos2016-07-15+ Add
Juliet® Ti (K153621)Spineart2016-07-15+ Add
Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device, Rampart A lumbar Interbody Fusion Device (K160906)Spineology, Inc.2016-07-14+ Add
PROW FUSION-V (K153786)Nlt Spine, Ltd.2016-07-11+ Add
MLX™ - Medial Lateral Expandable Lumbar Interbody System (K153105)Nu Vasive, Incorporated2016-07-11+ Add
AccuLIF TL and PL Cage (K160715)Stryker Corporation2016-07-08+ Add
Spinal Jaxx Interbody Fusion Device (K152501)Neuropro Spinaljaxx, Inc.2016-06-29+ Add
CoRoent® Ti-C System (K160916)Nu Vasive, Incorporated2016-06-28+ Add
Nanovis Intervertebral Body Fusion System and FortiCore® (K160874)Nanovis, LLC2016-06-28+ Add
Lucent Intervertebral Body Fusion Device (K152011)Spinal Elements, Inc.2016-06-09+ Add
LATERAL Spine Truss System (K153436)4Web, Inc.2016-06-06+ Add
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