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
Oct 16, 2013K130254PROW FUSION
Nlt Spine, Ltd.
MAX
Oct 10, 2013K131178IDYS LIF CAGES
Clariance
MAX
Oct 9, 2013K131981CEZANNE II INTERBODY FUSION SYSTEM
Accel Spine
MAX
Oct 4, 2013K132719STAXX IBL SYSTEM
Spine Wave, Inc.
MAX
Sep 26, 2013K132700PERIMETER INTERBODY FUSION DEVICE
Medtronic Sofamor Danek, Inc.
MAX
Sep 19, 2013K132479OPTICAGE INTERBODY FUSION DEVICE, MODEL 9080-00
Interventional Spine, Inc.
MAX
Sep 16, 2013K132053RAMPART-O, RAMPART-T
Spineology, Inc.
MAX
Sep 12, 2013K132505ACCULIF TL AND PL CAGE
Coalign Innovations, Inc.
MAX
Sep 3, 2013K131540INTERFUSE L INTERVERTEBRAL BODY FUSION DEVICE
Vertebral Technologies, Inc.
MAX
Sep 3, 2013K131296VARILIFT-L INTERBODY FUSION DEVICE
Wenzel Spine, Inc.
MAX
Sep 3, 2013K131242ARDIS INTERBODY SYSTEM
Zimmer Spine, Inc.
MAX
Aug 26, 2013K131082INTERFORM INTERBODY CAGE SYSTEM
Next Orthosurgical
MAX
Aug 20, 2013K131071STAXX IBL SYSTEM
Spine Wave, Inc.
MAX
Aug 8, 2013K130820EXPANDABLE LUMBAR INTERBODY SYSTEM
Nu Vasive, Incorporated
MAX
Jul 26, 2013K130478SUSTAIN AND SUSTAIN RADIOLUCENT SPACERS
Globus Medical, Inc.
MAX
Jul 25, 2013K123027CAPSTONE(R) SPINAL SYSTEM
Medtronic Sofamor Danek, Inc.
MAX
Jul 17, 2013K131077LIFE SPINE PLATEAU SPACER SYSTEM
Life Spine
MAX
Jul 5, 2013K131671MECTALIF
Medacta International
MAX
Jul 2, 2013K131372MOBIS II
Signus Medizintechnik GmbH
MAX
Jun 21, 2013K122957TEZO TITANIUM CAGE FAMILY
Ulrich GmbH & Co. KG
MAX
Jun 19, 2013K131443COALIGN INNOVATIONS ACCULIF XL IBF CAGE
Coalign Innovations, Inc.
MAX
Jun 13, 2013K130630PLATEAU SPACER SYSTEM TITANIUM
Life Spine, Inc.
MAX
Jun 4, 2013K124012INFILL OBLIQUE TLIF DEVICE
Pinnacle Spine Group, LLC
MAX
May 30, 2013K131216RAMPART O
Spineology, Inc.
MAX
May 30, 2013K130699ALEUTIAN SPINAL SYSTEM
K2m, Inc.
MAX
May 24, 2013K122639SYNTHES SYNCAGE EVOLUTION SPACER
Synthes (USA) Products, LLC
MAX
May 13, 2013K130506IMSE P-TLIF
Institute of Musculoskeletal Science & Education
MAX
May 13, 2013K123913LATIS SPACER
Globus Medical, Inc.
MAX
May 1, 2013K130434OCTANE STRAIGHT, OCTANE STRAIGHT - LORDOTIC, OCTANE STRAIGHT I/R, OCTANE STRAIGHT I/R - LORDOTIC
Exactech, Inc.
MAX
Apr 26, 2013K113781PANTHEON SPINAL IBFD SYSTEM
Pantheon Spinal
MAX
Apr 18, 2013K130548EPICAGE INTERBODY FUSION DEVICE
Alphatec Spine, Inc.
MAX
Apr 11, 2013K123461STAXX(R) IB SYSTEM
Spine Wave, Inc.
MAX
Apr 9, 2013K123978CAPSTONE L SPINAL SYSTEM
Medtronic Sofamor Danek USA
MAX
Apr 3, 2013K130194ACCULIF XL CAGE
Coalign Innovations, Inc.
MAX
Apr 1, 2013K123997TRANS1LATERAL INTERBODY FUSION SYSTEM
Trans1, Inc.
MAX
Mar 28, 2013K123100INTESS LUMBAR CAGE
Kalitec Direct, LLC
MAX
Mar 25, 2013K130396RAMPART O AND RAMPART P
Spineology, Inc.
MAX
Mar 22, 2013K123652SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DEVICE
Spineology, Inc.
MAX
Mar 22, 2013K122037ANATOMIC PEEK CERVICAL FUSION SYSTEM CORNERSTONE PSR CERVICAL FUSION SYSTEM PEEK PREVAIL CERVICAL INTERBODY DEVICE CAPST
Medtronic Sofamor Danek, Inc.
MAX
Mar 1, 2013K123602TM ARDIS INTERBODY SYSTEM INSERTER
Zimmer Trabecular Metal Technology
MAX
Feb 21, 2013K122967LUCENT
Spinal Elements, Inc.
MAX
Feb 7, 2013K123969XIPHOS
Difusion Technologies
MAX
Jan 23, 2013K123281ACCULIF TL-PEEK CAGE
Coalign Innovations, Inc.
MAX
Jan 18, 2013K123231CALIBER SPACERS
Globus Medical, Inc.
MAX
Jan 18, 2013K120464INNESIS PEEK CAGE
Bk Meditech, Co., Ltd.
MAX
Jan 14, 2013K123752ACCULIF TL AND PL CAGE
Coalign Innovations, Inc.
MAX
Jan 11, 2013K121254CAMBER SPINE TECHNOLOGIES TLS 5.0 INERBODY CAGE
Camber Spine Technologies
MAX
Jan 8, 2013K123180FALCON SPACER
Synthes (USA) Products, LLC
MAX
Dec 27, 2012K121693A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE AIS)
Sapphire Medical Group, Inc.
MAX
Dec 6, 2012K122097PATRIOT SPACERS
Globus Medical, Inc.
MAX

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