ClearanceBrief
Panels › Orthopedic › Product code MAX · Class 2

Intervertebral Fusion Device With Bone Graft, Lumbar

Regulation 888.3080

20510(k)s in 12 months (897 all time)
5recalls in 12 months (116 all time)
105recalls that name a 510(k)
Get daily alerts for MAXSample briefCSV

Top companies in MAX

Company510(k)sRecalls
Medtronic Sofamor Danek5512
Globus Medical, Inc.2022
Nu Vasive, Incorporated340
Life Spine330
Alphatec Spine223
Spineology, Inc.220
SeaSpine Orthopedics Corporation201
Spinal Elements172
Stryker170
K2m133
Decided510(k)Device and applicantCode
Dec 4, 2017K172419Velofix™ TLIF Cage
U&I Corporation, KR
MAX
Dec 1, 2017K170553Altus Spine Interbody Fusion System
Altus Partners, LLC
MAX
Nov 29, 2017K172020Arlington PLIF/TLIF Cage
Signature Orthopaedics Pty, Ltd., AU
MAX
Nov 29, 2017K170235Lucent®
Spinal Elements, Inc.
MAX
Nov 13, 2017K163595IMPIX 3D Print Cages
Medicrea International SA, FR
MAX
Nov 7, 2017K172392Lateral Spinal Truss System (LSTS) Interbody Fusion Device
4Web, Inc.
MAX
Nov 2, 2017K170341Medussa-PL Cage
Medyssey USA, Inc.
MAX
Oct 31, 2017K173080IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF)
Huvexel Co. , Ltd., KR
MAX
Oct 26, 2017K173022SeaSpine Ventura NanoMetalene System
SeaSpine Orthopedics Corporation
MAX
Oct 26, 2017K172341NuVasive® Modulus TLIF Interbody System
Nu Vasive, Incorporated
MAX
Oct 25, 2017K172334Ortus™ Expandable Lumbar Interbody Fusion System
Atlas Spine, Inc.
MAX
Oct 25, 2017K171914Cortina™ Lumbar Cage System
Neurostructures, Inc.
MAX
Oct 23, 2017K172343Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D Technology
Rti Surgical, Inc.
MAX
Oct 11, 2017K172123NuVasive® Modulus XLIF Interbody System
Nu Vasive, Incorporated
MAX
Oct 5, 2017K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with TiONIC Technology
Medtronic Sofamor Danek USA, Inc.
MAX
Sep 29, 2017K170119Calix Lumbar Spinal Implant System
X-Spine Systems, Inc.
MAX
Sep 28, 2017K171633NuVasive TLX Interbody System
Nu Vasive, Incorporated
MAX
Sep 26, 2017K171107CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal System
Medtronic Sofamor Danek USA, Inc.
MAX
Sep 19, 2017K172199ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium
Medtronic Sofamor Danek
MAX
Sep 15, 2017K172064Ti-Diagon Oblique TLIF
Camber Spine Technologies
MAX
Sep 15, 2017K171519FLXfit™
Expanding Orthopedics, Inc.
MAX
Sep 8, 2017K171893Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone Synergy Cervical Interbody Fusion Sy
Bluestone Synergy
MAX
Sep 8, 2017K171351Posterior Spine Truss System (PSTS) Interbody Fusion Device
4Web, Inc.
MAX
Aug 29, 2017K171329Altus Spine Titanium Interbody Fusion System
Altus Partners, LLC
MAX
Aug 18, 2017K171660Duo Lumbar Interbody Fusion Device
Spineology, Inc.
MAX
Aug 11, 2017K171657ShurFit 2C Lumbar Interbody Fusion System
Precision Spine, Inc.
MAX
Aug 8, 2017K170888Renovis S141 Lumbar Interbody Fusion System
Renovis Surgical Technologies
MAX
Aug 7, 2017K170851Anterior Spine Truss System (STS) Interbody Fusion Device
4Web, Inc.
MAX
Aug 3, 2017K170919The TiBow Expandable Spacer System
Life Spine, Inc.
MAX
Jul 25, 2017K171630LumFuse-TP
Precifit Medical, Ltd.
MAX
Jul 24, 2017K171724Rampart L Lumbar Interbody Fusion Device
Spineology, Inc.
MAX
Jul 20, 2017K171425CONCORDE LIFT
Medos International SARL, CH
MAX
Jul 13, 2017K171656Genesys Spine Apache Interbody Fusion System
Genesys Spine
MAX
Jul 13, 2017K170676HD Lumbar Interbody System
Hd Lifesciences, LLC
MAX
Jul 11, 2017K170503EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular Titanium TLIF Cages, and EIT Cellula
Eit Emerging Implant Technologies GmbH, DE
MAX
Jul 6, 2017K171031CRESCENT™ Spinal System
Medtronic Sofamor Danek
MAX
Jul 6, 2017K170399Endoskeleton TO Interbody Fusion Device (IBD)
Titan Spine, LLC
MAX
Jun 29, 2017K161710SAGICO IBF SYSTEM – ARIA LUMBAR, SAGICO IBF SYSTEM – ARION CERVICAL
Spinal Analytics & Geometrical Impant Co, LLC
MAX
Jun 27, 2017K170297Tranquil Interbody System
Nexus Spine, LLC
MAX
Jun 26, 2017K170962NuVasive® CoRoent® Thoracolumbar System
Nu Vasive, Incorporated
MAX
Jun 19, 2017K163506Coalesce™ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar Interbody Fusion System
Vertera, Inc.
MAX
Jun 13, 2017K171468FUSE Spinal System
Medtronic Sofamor Danek
MAX
Jun 12, 2017K162986SPIRA Open Matrix ALIF
Camber Spine Technologies
MAX
Jun 2, 2017K170890TELIX K Interbody System
Biedermann Motech GmbH & Co. KG, DE
MAX
Jun 2, 2017K170395Talos® Lumbar (HA) PEEK IBF Devices
Meditech Spine, LLC
MAX
May 19, 2017K162212DIVERGENCE-L ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM
Medtronic Sofamor Danek USA, Inc.
MAX
May 10, 2017K171097MOJAVE Expandable Interbody System
K2m, Inc.
MAX
May 3, 2017K163481HALF DOME Posterior Lumbar Interbody System
Astura Medical
MAX
May 1, 2017K163707NuVasive CoRoent Ti-C System
Nu Vasive, Incorporated
MAX
Apr 26, 2017K170572Summit Spine Yellowstone Lumbar Interbody Fusion System
Summit Spine
MAX

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.