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)
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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
Mar 24, 2022K220655X-Pac Expandable Lumbar Cage System
Expanding Innovations, Inc.
MAX
Mar 24, 2022K220453FlareHawk Interbody Fusion System
Integrity Implants, Inc.
MAX
Mar 9, 2022K220096Genesys Spine 3DP Lumbar Interbody System
Genesys Spine
MAX
Mar 9, 2022K213441PathLoc Lumbar Interbody Fusion Cage System
L&K BIOMED Co., Ltd., KR
MAX
Feb 16, 2022K212930LumiVy Lumbar IBF System
Vy Spine, LLC
MAX
Jan 5, 2022K213951FORZA XP Expandable Spacer System
Orthofix US, LLC
MAX
Dec 23, 2021K203714NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System, NuVasive CoRoent XL Interfixated System
Nu Vasive, Incorporated
MAX
Dec 8, 2021K212524Anteralign Spinal System with Titan nanoLOCK Surface Technology
Medtronic Sofamor Danek USA, Inc.
MAX
Dec 8, 2021K212075ShurFit Lumbar Interbody System
Precision Spine, Inc.
MAX
Dec 1, 2021K212050NGM WAVE PLIF Cage
NGMedical GmbH, DE
MAX
Nov 19, 2021K212653Catalyft LS Expandable Interbody System
Medtronic Sofamor Danek USA, Inc.
MAX
Nov 16, 2021K211845Deploy Expandable Interbody System
Southern Spine, LLC
MAX
Nov 1, 2021K212823DePuy CONDUIT LLIF Angled Inserters
Enztec Limited, NZ
MAX
Oct 29, 2021K212831MectaLIF Extension
Medacta International S.A., CH
MAX
Oct 29, 2021K212389Advantage Lumbar System - ALIF, PLIF, DLIF, TLIF
Intelivation, LLC
MAX
Oct 8, 2021K212520ProLift Micro Expandable Spacer System
Life Spine, Inc.
MAX
Sep 29, 2021K211740DualX
Amplify Surgical, Inc.
MAX
Sep 22, 2021K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec Interbody System, Transcend NanoT
Alphatec Spine, Inc.
MAX
Sep 21, 2021K211689KEYSTONE PEEK Cage System
Shanghai Sanyou Medical Co, Ltd., CN
MAX
Sep 14, 2021K211474Kleiner KG2 System
BAAT Medical Products B.V., NL
MAX
Sep 10, 2021K212540Explorer TO System
SeaSpine Orthopedics Corporation
MAX
Sep 1, 2021K203014EndoLIF Delta-Cage and DoubleWedge-Cage
Joimax GmbH, DE
MAX
Aug 30, 2021K212070KMTI S141 Lumbar Interbody Fusion System
Kyocera Medical Technologies, Inc.
MAX
Aug 30, 2021K210090Impulse AM Interbody Fusion System
Degen Medical
MAX
Aug 27, 2021K211413BEE PLIF Cage
NGMedical GmbH, DE
MAX
Aug 20, 2021K210800IO Expandable Lumbar Interbody Fusion System
MiRus, LLC
MAX
Aug 10, 2021K211873PSX Interbody System
Alphatec Spine, Inc.
MAX
Aug 5, 2021K211388Lateral Spine Truss System (LSTS) Interbody Fusion Device
4Web Medical, Inc.
MAX
Jul 7, 2021K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu a•POD-L NanoMetalene, SeaSpine Vu e•
SeaSpine Orthopedics Corporation
MAX
Jul 7, 2021K203003Pantheon IBFD
Pantheon Spinal
MAX
Jun 30, 2021K210542aprevo Transforaminal IBF
Carlsmed, Inc.
MAX
Jun 30, 2021K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System, Ceres-C Spinal System, Omega XP S
Spinal Elements, Inc.
MAX
Jun 24, 2021K211306LABYRINTH
Zavation Medical Products, LLC
MAX
Jun 15, 2021K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar Spacers
Camber Spine Technologies, LLC
MAX
Jun 7, 2021K203802X-Pac Expandable Lumbar Cage System
Expanding Innovations, Inc.
MAX
Jun 2, 2021K210583SeaSpine WaveForm™ A Interbody System
SeaSpine Orthopedics Corporation
MAX
May 26, 2021K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA Interbody System, Endoskeleton TAS
Medtronic Sofamor Danek USA, Inc.
MAX
May 24, 2021K210425Catalyft PL Expandable Interbody System
Medtronic Sofamor Danek USA, Inc.
MAX
May 24, 2021K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody System
Nu Vasive, Incorporated
MAX
May 12, 2021K210439NuVasive MOD-EX XLIF Interbody System
Nu Vasive, Incorporated
MAX
May 6, 2021K210728CONDUIT Instruments
Medos International SARL, CH
MAX
Apr 30, 2021K210061ProLift Lateral HELO Fixated
Life Spine, Inc.
MAX
Apr 29, 2021K201024Expandable Titanium PLIF/TLIF System
Spectrum Spine, LLC
MAX
Apr 12, 2021K200919Idys ALIF 3DTi
Clariance, FR
MAX
Mar 26, 2021K203254Lucent 3D Spinal System
Spinal Elements, Inc.
MAX
Mar 26, 2021K203038Toro-L Interbody Fusion System
Integrity Implants, Inc.
MAX
Mar 17, 2021K203361ProLift Wedge Expandable Spacer System
Life Spine, Inc.
MAX
Mar 10, 2021K210359Hexanium TLIF
Spinevision, S.A.S., FR
MAX
Mar 3, 2021K203576FORZA Ti Spacer System
Orthofix, Inc.
MAX
Feb 19, 2021K210155Duo Expandable Interbody Fusion System
Spineology, Inc.
MAX

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