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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
Nov 29, 2012K123207PRIMALIF TM LLIF UNITARY PEEK LATERAL LUMBAR INTERBODY FUSION SYSTEM
Osteomed LP
MAX
Oct 25, 2012K122956FUSELOX LUMBAR INTERBODY FUSION DEVICE
Captiva Spine
MAX
Oct 24, 2012K122989BIOMET LATERAL SPACER SYSTEM
Biomet Spine (Aka Ebi, LLC)
MAX
Oct 18, 2012K122896COUGAR LS 15 LATERAL CAGE SYSTEM
Medos International SARL
MAX
Oct 17, 2012K121581BOX PEEK VBR SYSTEM,
Innovasis, Inc.
MAX
Oct 5, 2012K120401ALAMO T
Alliance Partners, LLC
MAX
Sep 26, 2012K121567ORACLE LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM
Accel Spine
MAX
Sep 20, 2012K122021STERISPINE LC CAGE
Safe Orthopaedics, FR
MAX
Sep 18, 2012K122591CLYDESDALE SPINAL SYSTEM
Medtronic Sofamor Danek, Inc.
MAX
Sep 4, 2012K122047ALAMO P
Alliance Partners, LLC
MAX
Aug 29, 2012K122317TETRIS II
Signus Medizintechnik GmbH
MAX
Aug 29, 2012K121760CAPSTONE SPINAL SYSTEM
Medtronic Sofamor Danek USA, Inc.
MAX
Aug 24, 2012K121892PHANTOM PLUS CERAMIC CAGE SYSTEM
Amedica Corp.
MAX
Aug 23, 2012K120991TRANS1 INTERBODY FUSION SYSTEM
Trans1 Incorporated
MAX
Jul 13, 2012K121733INFILL INTERVERTEBRAL BODY FUSION DEVICE
Pinnacle Spine Group, LLC
MAX
Jul 6, 2012K121096VENUS LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM
L&K BIOMED Co., Ltd., KR
MAX
Jul 5, 2012K121683ACCULIF TL CAGE
Coalign Innovations, Inc.
MAX
Jul 3, 2012K120966DEPUY PULSE LUMBAR CAGE SYSTEM
Medos International SARL
MAX
Jun 29, 2012K121333WAVE D CAGE
Advanced Medical Technologies AG
MAX
Jun 29, 2012K121332LOOP CAGE
Advanced Medical Technologies AG
MAX
Jun 29, 2012K121330WAVE O CAGE
Advanced Medical Technologies AG
MAX
Jun 29, 2012K121288FUSE CAGE
Advanced Medical Technologies AG, DE
MAX
Jun 28, 2012K120918NUVASIVE COROENT TITANIUM SYSTEM
Nuvasive, Inc.
MAX
Jun 15, 2012K121246MEDYSSY LT CAGE SYSTEM
Medyssey Co, Ltd.
MAX
Jun 15, 2012K120203TM-400 DEVICE
Zimmer Trabecular Metal Technology, Inc.
MAX
Jun 13, 2012K121129SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DEVICE
Spineology, Inc.
MAX
May 29, 2012K113561TM ARDIS INTERBODY SYSTEM TM ARDIS INTERBODY SYSTEM INSTRUMENATION
Zimmer Trabecular Metal Technology
MAX
May 23, 2012K110632LUCENT OR LUCENT MAGNUM
Spinal Elements, Inc.
MAX
May 8, 2012K121116PLATEAU SPACER SYSTEM
Life Spine
MAX
May 1, 2012K112986LATERAL FUSION DEVICE
Integra Spine (Integra Lifesciences)
MAX
Apr 19, 2012K120063VENUS LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM
L&K BIOMED Co., Ltd., KR
MAX
Apr 18, 2012K112696TWIN PEAKS LUMBAR CAGE
Qualgenix, LLC
MAX
Apr 9, 2012K120368CAPSTONE CONTROL SPINAL SYSTEM
Medtronic Sofamor Danek USA, Inc.
MAX
Mar 28, 2012K120576ZAVATION IBF SYSTEM
Zavation, LLC
MAX
Mar 13, 2012K112648ASFORA BULLET CAGE
Medical Designs, LLC
MAX
Mar 12, 2012K113540RELIANCE LUMBAR IBF SYSTEM
Reliance Medical Systems, LLC
MAX
Mar 5, 2012K113478PLIF CAGE
Eisertech, LLC
MAX
Mar 5, 2012K111792MOBIS, MOVAL, SEMIAL, TETRISMODEL PEEK AND TITANIUM, KIMBA MODEL STANDARD AND MINI
Signus Medizintechnik GmbH
MAX
Feb 29, 2012K120293SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DRIVE
Spineology, Inc.
MAX
Feb 28, 2012K120024MECTALIF TRANSFORAMINAL
Medacta International S.A.
MAX
Feb 6, 2012K113642PERIMETER INTERBODY FUSION DEVICE
Medtronic Sofamor Danek USA
MAX
Feb 6, 2012K111726PATHWAY AVID
Custom Spine, Inc.
MAX
Jan 26, 2012K113447RISE SPACER
Globus Medical, Inc.
MAX
Jan 26, 2012K113030SPINEOLOGY PEEK BULLET LUMBAR INTERBODY FUSION DEVICE
Spineology, Inc.
MAX
Jan 20, 2012K113527OPTICAGE INTERBODY FUSION DEVICE
Interventional Spine, Inc.
MAX
Jan 10, 2012K113138ALEUTIAN SYSTEM
K2m, Inc.
MAX
Dec 20, 2011K113528CLYDESDALE(R) SPINAL SYSTEM
Medtronic Sofamor Danek USA, Inc.
MAX
Dec 14, 2011K1123164-WEB ALIF SPINAL TRUSS SYSTEM (STS)
4-Web, Inc.
MAX
Dec 13, 2011K113348COUGAR SYSTEM
Johnson & Johnson
MAX
Dec 12, 2011K113465ACCULIF TL CAGE
Coalign Innovations, Inc.
MAX

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