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MAX

895 FDA 510(k) clearances · Product code

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RecordFirmDateBuilder
PLIF LITE AND TLIF LITE (K132907)Sintea Plustek2014-07-24+ Add
CHOICE SPINE LUMBAR SPACER SYSTEM (SABRE, SHARK, HORNET, HARPOON) (K140142)Choicespine, LP2014-07-16+ Add
ACCULIF TL AND PL CAGE (K141217)Stryker Corporation2014-07-16+ Add
MILESTONE SPINAL SYSTEM (K133053)Weigao Orthopaedic Device Co., Ltd.2014-07-15+ Add
FLXFIT INTERVERTEBRAL BODY FUSION DEVICE (K133813)Expanding Orthopedics, Inc.2014-07-15+ Add
ENDOSKELETON(R) TL INTERBODY FUSION DEVICE (K140055)Titan Spine, LLC2014-07-02+ Add
AP EXPANDABLE XLIF SYSTEM (K140162)Nuvasive, Inc.2014-07-02+ Add
ALTERA SPACER (K140411)Globus Medical, Inc.2014-07-01+ Add
COROENT THORACOLUMBAR IMPLANTS (K140659)Nu Vasive, Incorporated2014-06-26+ Add
BENGAL SYSTEM, BENGAL STACKABLE SYSTEM, CONCORDE BULLET LUMBAR, CONCORDE INLINE LUMBAR, COUGAR SYSTEM, COUGAR LS LATERAL (K140759)Medos International SARL2014-06-13+ Add
BN LUMBAR CAGE SYSTEM (K140564)Medyssey USA, Inc.2014-06-05+ Add
PEEK CAGE FOR THE VERTEBRAL SPINE (K132852)Neoortho Produtos Ortopedicos S/A2014-05-29+ Add
SKYHAWK INTERBODY FUSION SYSTEM (K140709)Orthofix, Inc.2014-05-27+ Add
INTEGRA EXPANDABLE INTERVEREBRAL BODY FUSION DEVICE (IBD) SYSTEM (K133418)Seaspine, Inc.2014-05-01+ Add
XCAGE INTERBODY FUSION SYSTEM (K133514)Ouroboros Medical2014-05-01+ Add
OCTANE ELEVATE SPINAL IMPLANT SYSTEM (K123607)Exactech, Inc.2014-04-25+ Add
ALAMO T (K140303)Alliance Partners, LLC2014-04-21+ Add
JULIET OL (K140474)Spineart2014-04-18+ Add
ANYPLUS; ALIF PEEK CAGES, PLIF PEEK CAGES, T-PLIF PEEK CAGES, TLIF PEEK CAGES (K131612)GS Medical Co., Ltd.2014-04-18+ Add
COGENT MED-LIF (K132738)Cogent Spine, LLC2014-04-15+ Add
SPINEWORKS ANTERIOR LUMBAR DEVICE (K133340)Spineworks, LLC2014-04-11+ Add
ABACUS TM SPACER SYSTEM (K140007)Spine Wave, Inc.2014-04-07+ Add
ALEUTIAN IBF SYSTEM (K133614)K2m, Inc.2014-04-03+ Add
INFILL 41-TLIF CONVEX OBLIQUE DEVICE, INFILL 43-TLIF CONTOUR OBLIQUE, INFILL 44-TLIF CONTOUR OBLIQUE AND THE INFILL 60 (K133721)Pinnacle Spine Group, LLC2014-03-31+ Add
CROSSFUSE II CORONAL TAPER, CROSSFUSE II HYPERLORDOTIC (K133455)Pioneer Surgical Technology, Inc.2014-03-27+ Add
CAMBER SPINE DIAGON OBLIQUE CAGE (K134038)Camber Spine2014-03-20+ Add
STERISPINE LC CAGE (K133893)Safe Orthopaedics2014-03-14+ Add
CAPSTONE PTC SPINAL SYSTEM, CLYDESDALE PTC SPINAL SYSTEM (K133205)Medtronic Sofamor Danek USA, Inc.2014-03-13+ Add
ELITE IBF (K133459)Innova Spinal Technologies, LLC2014-03-06+ Add
OPTICAGE INTERBODY FUSION DEVICE, MODEL SERIES 9070 (K133583)Interventional Spine, Inc.2014-02-10+ Add
JULIET LL LATERAL LUMBAR CAGE (K133557)Spineart2014-02-03+ Add
DEROYAL SPINE SPACER SYSTEM (K131292)Deroyal Industries, Inc.2014-02-03+ Add
INTERBODY CAGE SYSTEM (K133967)Aurora Spine2014-01-31+ Add
ARDIS INTERBODY SYSTEM (K133184)Zimmer Spine, Inc.2014-01-30+ Add
MECTALIF TIPEEK (K133192)Medacta International2014-01-30+ Add
AESCULAP PEEK XP SPINAL IMPLANT SYSTEM (K132421)Aesculap Implant Systems, Inc.2014-01-22+ Add
RAMPART-L (K133371)Spineology, Inc.2014-01-09+ Add
PERIMETER C SPINAL SYSTEM, CAPSTONE SPINAL SYSTEM, CAPSTONE L SPINAL SYSTEM, PERIMETER SPINAL SYSTEM (K133645)Medtronic Sofamor Danek USA, Inc.2014-01-03+ Add
COROENT STERILE IMPLANTS SYSTEM (K132601)Nu Vasive, Incorporated2013-12-24+ Add
CAPSTONE SPINAL SYSTEM (K133650)Medtronic Sofamor Danek USA, Inc.2013-12-20+ Add
INFIX ANTERIOR LUMBAR SYSTEM (K132790)Zimmer Spine, Inc.2013-12-20+ Add
GENESYS SPINE APACHE LATERAL LUMBAR INTERBODY FUSION SYSTEM (K130913)Genesys Spine2013-12-13+ Add
CLYDESDALE SPINAL SYSTEM (K132897)Medtronic Sofamor Danek, Inc.2013-12-11+ Add
K7 LUMBAR SPACERS (K133126)K7, LLC2013-12-09+ Add
CRESCENT SPINAL SYSTEM (K133216)Medtronic Sofamor Danek, Inc.2013-11-22+ Add
PERIMETER INTERBODY FUSION DEVICE (K131669)Medtronic Sofamor Danek USA, Inc.2013-11-01+ Add
BIOLIGN ACIF SYSTEMS, BIOLIGN STACC ACIF SYSTEM, BIOLIGN TLIF SYSTEM (K130274)Elite Surgical Supplies (Pty), Ltd.2013-10-29+ Add
CALIX LUMBAR SPINAL IMPLANT SYSTEM (K131350)X-Spine Systems, Inc.2013-10-23+ Add
PROW FUSION (K130254)Nlt Spine, Ltd.2013-10-16+ Add
IDYS LIF CAGES (K131178)Clariance2013-10-10+ Add
CEZANNE II INTERBODY FUSION SYSTEM (K131981)Accel Spine2013-10-09+ Add
STAXX IBL SYSTEM (K132719)Spine Wave, Inc.2013-10-04+ Add
PERIMETER INTERBODY FUSION DEVICE (K132700)Medtronic Sofamor Danek, Inc.2013-09-26+ Add
OPTICAGE INTERBODY FUSION DEVICE, MODEL 9080-00 (K132479)Interventional Spine, Inc.2013-09-19+ Add
RAMPART-O, RAMPART-T (K132053)Spineology, Inc.2013-09-16+ Add
ACCULIF TL AND PL CAGE (K132505)Coalign Innovations, Inc.2013-09-12+ Add
ARDIS INTERBODY SYSTEM (K131242)Zimmer Spine, Inc.2013-09-03+ Add
INTERFUSE L INTERVERTEBRAL BODY FUSION DEVICE (K131540)Vertebral Technologies, Inc.2013-09-03+ Add
VARILIFT-L INTERBODY FUSION DEVICE (K131296)Wenzel Spine, Inc.2013-09-03+ Add
INTERFORM INTERBODY CAGE SYSTEM (K131082)Next Orthosurgical2013-08-26+ Add
STAXX IBL SYSTEM (K131071)Spine Wave, Inc.2013-08-20+ Add
EXPANDABLE LUMBAR INTERBODY SYSTEM (K130820)Nu Vasive, Incorporated2013-08-08+ Add
SUSTAIN AND SUSTAIN RADIOLUCENT SPACERS (K130478)Globus Medical, Inc.2013-07-26+ Add
CAPSTONE(R) SPINAL SYSTEM (K123027)Medtronic Sofamor Danek, Inc.2013-07-25+ Add
LIFE SPINE PLATEAU SPACER SYSTEM (K131077)Life Spine2013-07-17+ Add
MECTALIF (K131671)Medacta International2013-07-05+ Add
MOBIS II (K131372)Signus Medizintechnik GmbH2013-07-02+ Add
TEZO TITANIUM CAGE FAMILY (K122957)Ulrich GmbH & Co. KG2013-06-21+ Add
COALIGN INNOVATIONS ACCULIF XL IBF CAGE (K131443)Coalign Innovations, Inc.2013-06-19+ Add
PLATEAU SPACER SYSTEM TITANIUM (K130630)Life Spine, Inc.2013-06-13+ Add
INFILL OBLIQUE TLIF DEVICE (K124012)Pinnacle Spine Group, LLC2013-06-04+ Add
ALEUTIAN SPINAL SYSTEM (K130699)K2m, Inc.2013-05-30+ Add
RAMPART O (K131216)Spineology, Inc.2013-05-30+ Add
SYNTHES SYNCAGE EVOLUTION SPACER (K122639)Synthes (USA) Products, LLC2013-05-24+ Add
LATIS SPACER (K123913)Globus Medical, Inc.2013-05-13+ Add
IMSE P-TLIF (K130506)Institute of Musculoskeletal Science & Education2013-05-13+ Add
OCTANE STRAIGHT, OCTANE STRAIGHT - LORDOTIC, OCTANE STRAIGHT I/R, OCTANE STRAIGHT I/R - LORDOTIC (K130434)Exactech, Inc.2013-05-01+ Add
PANTHEON SPINAL IBFD SYSTEM (K113781)Pantheon Spinal2013-04-26+ Add
EPICAGE INTERBODY FUSION DEVICE (K130548)Alphatec Spine, Inc.2013-04-18+ Add
STAXX(R) IB SYSTEM (K123461)Spine Wave, Inc.2013-04-11+ Add
CAPSTONE L SPINAL SYSTEM (K123978)Medtronic Sofamor Danek USA2013-04-09+ Add
ACCULIF XL CAGE (K130194)Coalign Innovations, Inc.2013-04-03+ Add
TRANS1LATERAL INTERBODY FUSION SYSTEM (K123997)Trans1, Inc.2013-04-01+ Add
INTESS LUMBAR CAGE (K123100)Kalitec Direct, LLC2013-03-28+ Add
RAMPART O AND RAMPART P (K130396)Spineology, Inc.2013-03-25+ Add
SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DEVICE (K123652)Spineology, Inc.2013-03-22+ Add
ANATOMIC PEEK CERVICAL FUSION SYSTEM CORNERSTONE PSR CERVICAL FUSION SYSTEM PEEK PREVAIL CERVICAL INTERBODY DEVICE CAPST (K122037)Medtronic Sofamor Danek, Inc.2013-03-22+ Add
TM ARDIS INTERBODY SYSTEM INSERTER (K123602)Zimmer Trabecular Metal Technology2013-03-01+ Add
LUCENT (K122967)Spinal Elements, Inc.2013-02-21+ Add
XIPHOS (K123969)Difusion Technologies2013-02-07+ Add
ACCULIF TL-PEEK CAGE (K123281)Coalign Innovations, Inc.2013-01-23+ Add
INNESIS PEEK CAGE (K120464)Bk Meditech, Co., Ltd.2013-01-18+ Add
CALIBER SPACERS (K123231)Globus Medical, Inc.2013-01-18+ Add
ACCULIF TL AND PL CAGE (K123752)Coalign Innovations, Inc.2013-01-14+ Add
CAMBER SPINE TECHNOLOGIES TLS 5.0 INERBODY CAGE (K121254)Camber Spine Technologies2013-01-11+ Add
FALCON SPACER (K123180)Synthes (USA) Products, LLC2013-01-08+ Add
A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE AIS) (K121693)Sapphire Medical Group, Inc.2012-12-27+ Add
PATRIOT SPACERS (K122097)Globus Medical, Inc.2012-12-06+ Add
PRIMALIF TM LLIF UNITARY PEEK LATERAL LUMBAR INTERBODY FUSION SYSTEM (K123207)Osteomed LP2012-11-29+ Add
FUSELOX LUMBAR INTERBODY FUSION DEVICE (K122956)Captiva Spine2012-10-25+ Add
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