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
Dec 1, 2011K112095ACCULIF TL-PEEK IBF CAGE
Coalign Innovations, Inc.
MAX
Nov 21, 2011K112405CLYDESDALES SPINAL SYSTEM
Medtronic Sofamor Danek USA, Inc.
MAX
Nov 9, 2011K110562TELAMON PEEK SPINAL SYSTEM
Medtronic Sofamor Danek USA
MAX
Nov 8, 2011K112359PROW FUSION
Nlt Spine, Ltd.
MAX
Oct 26, 2011K111512BONEBAC T-PLIF INTERVERTEBRAL BODY FUSION DEVICE SYSTEM
Thompson Mis, Inc.
MAX
Oct 25, 2011K111965VUSION(R) OS
Ortho Development
MAX
Oct 24, 2011K110783VENUS INTERBODY FIXATION SYSTEM- VENUS PLIF/TLIF, ALIF PEEK CAGE
L&K BIOMED Co., Ltd., KR
MAX
Oct 17, 2011K112014ZYSTON STRAIGHT SPACER SYSTEM
Biomet Spine
MAX
Oct 17, 2011K111354GS MEDICAL ANYPLUS PEEK LUMBAR CAGES (ALIF AND DLIF)
GS Medical Co., Ltd.
MAX
Oct 11, 2011K110694CONCORDE BULLET SPINAL SYSTEM
Johnson & Johnson
MAX
Sep 28, 2011K112496PIONEER CROSSFUSE II IBF/VBR SYSTEM
Pioneer Surgical Technology, Inc.
MAX
Sep 28, 2011K111553SPINEFRONTIER LUMBAR IBF SYSTEM
Spinefrontier, Inc.
MAX
Sep 26, 2011K111880SPINEOLGY PEEK BULLET LUMBER INTERBODY FUSION DEVICE
Spineology, Inc.
MAX
Sep 13, 2011K110659MEDICAL CONCEPTS INTERBODY FUSION SYSTEM
Medical Concepts, Inc.
MAX
Sep 8, 2011K111166A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE A.I.S.)
Spineworks, LLC
MAX
Aug 24, 2011K111525PERIMETER INTERBODY FUSION DEVICE
Medtronic Sofamor Danek
MAX
Aug 9, 2011K110543CRESCENT (R) SPINAL SYSTEM TITANIUM
Medtronic Sofamor Danek USA, Inc.
MAX
Jul 21, 2011K100305ETURN SPINAL IMPLANT MODEL ETURN XX-12; ETURN XX-16 WHERE XX=07, 09, 11, 13, OR 15 AND ETURN XX-12 K; ETURN XX-16 K WHER
Icotec
MAX
Jul 20, 2011K111774PATHWAY MODEL 07XXXX
Custom Spine
MAX
Jul 18, 2011K103731CAPSTONE R SPINAL SYSTEM
Medtronic Sofamor Danek
MAX
Jul 6, 2011K111569PLATEAU SPACER SYSTEM
Life Spine
MAX
Jun 30, 2011K110650ZYSTON ARC INTERBODY SPACER
Biomet Spine (Aka Ebi, LLC)
MAX
Jun 22, 2011K110843ALEUTIAN SPACER SYSTEM
K2m, Inc.
MAX
Jun 13, 2011K110933SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DEVICE
Spineology, Inc.
MAX
Jun 13, 2011K110927MECTALIF
Medacta International
MAX
May 27, 2011K110226INTERFUSE T INVERTEBRAL BODY FUSION DEVICE
Vertebral Technologies, Inc.
MAX
May 13, 2011K110454COUGAR LS LATERAL CAGE SYSTEM
Johnson & Johnson
MAX
May 12, 2011K102026SEASPINE SPACER SYSTEM
Seaspine, Inc.
MAX
Apr 28, 2011K102957CUTTING EDGE SPINE INTERBODY FUSION DEVICE
Cutting Edge Spine, LLC
MAX
Apr 21, 2011K110177HELENA SYSTEM
Royal Oak Medical Devices
MAX
Apr 18, 2011K103729INFILL INTERVERTEBRAL BODY FUSION DEVICE
Pinnacle Spine Group, LLC
MAX
Apr 8, 2011K110067LP CAGE
Medyssey Co, Ltd.
MAX
Apr 7, 2011K110270ACCULIF CAGE
Coalign Innovations, Inc.
MAX
Mar 23, 2011K103666LANX LATERAL
Lanx, Inc.
MAX
Mar 23, 2011K103111FORZA SPACER SYSTEM
Orthofix, Inc.
MAX
Mar 17, 2011K103814PEZO INTERBODY CAGES SYSTEM
Ulrich GmbH & Co. KG
MAX
Mar 17, 2011K103743CONCORDE CURVE SYSTEM
Johnson & Johnson
MAX
Mar 2, 2011K103488CONCORDE BULLET CAGE SYSTEM
Johnson and Johnson
MAX
Feb 9, 2011K100945FUSE PLIF CAFE
Advanced Medical Technologies AG
MAX
Feb 3, 2011K110045INTERFUSE DA INVERTEBRAL BODY FUSION DEVICE
Vertebral Technologies, Inc.
MAX
Jan 27, 2011K103297REDONDO-L
Seaspine, Inc.
MAX
Jan 18, 2011K083894ALIF SPINAL TRUSS INTERBODY FUSION DEVICE
4-Web Spine, LLC
MAX
Jan 7, 2011K102322STINGRAY CERVICAL CAGE; SHARK IMPLANT (PLIF); BULL SHARK IMPLANT(PLIF); TIGER IMPLANT (TLIF); GREAT WHITE IMPLANTS(ALIF)
Omni Surgical, L.P.
MAX
Jan 5, 2011K103228PARAMOUNT R IBF DEVICE
Theken Spine, LLC
MAX
Jan 5, 2011K102293CALIBER SPACER
Globus Medical, Inc.
MAX
Dec 10, 2010K103034GENESYS SPINE INTERBODY FUSION SYSTEM
Genesys Spine
MAX
Dec 3, 2010K102313PATRIOT TRANSCONTINENTAL M SPACERS
Globus Medical, Inc.
MAX
Dec 1, 2010K101923CONCORDE CURVE SYSTEM
Depuy Spine
MAX
Nov 5, 2010K102067ENDOSKELETON TO
Titan Spine, LLC
MAX
Oct 6, 2010K102277INTERFUSE T INVERTEBRAL BODY FUSION DEVICE
Vertebral Technologies, Inc.
MAX

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