510(k) Report

Devices descending from K080588

250 later devices reach Scient'x Tribeca VBR through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172480icotec Interbody Cage SystemIcotec AG20185—
+1K170503EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH20171992
+1K162986SPIRA Open Matrix ALIFCamber Spine Technologies201711—
+1K152355Twin Peaks Lumbar Interbody Fusion SystemSpineway20151—
+1K112801Ayers Rock Cervical CageQualgenix20122—
+1K112696Twin Peaks Lumbar CageQualgenix, LLC20120—
+1K101363VU Cpod Intervertebral Bodu Fusion DeviceMusculoskeletal Clinical Regulatory Advisers201078—
+2K2530413d Cage CervicalFims Co., Ltd.20260—
+2K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+2K261067BEE PLIF CageNGMedical GmbH20260—
+2K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+2K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+2K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—
+2K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+2K211413BEE PLIF CageNGMedical GmbH20211—
+2K200429BEE CagesNGMedical GmbH202111—
+2K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+2K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC20200—
+2K200312Tryptik TiSpineart20202—
+2K192897icotec Cervical CageIcotec AG20201—
+2K193378CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd.20202—
+2K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+2K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+2K1803473d CageFims Co., Ltd.20190—
+2K190483SPIRA Open Matrix ALIF and LLIFCamber Spine Technologies20199—
+2K183092Kuros TLIF CageKuros Biosciences B.V20190—
+2K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960—
+2K183447EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH2019131—
+2K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+2K180724SPIRA Open Matrix LLIFCamber Spine Technologies, LLC201810—
+2K173347STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX…Centinel Spine, Inc.201812—
+2K172926SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation201761—
+2K172888EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH2017159—
+2K163265Kepler IIOrbbo Surgical, LLC20170—
+2K162694Ayers Rock Cervical interbody fusion systemSpineway20170—
+2K163180Hubble IIOrbbo Surgical, LLC20160—
+2K112862Mecta-CMedacta International201114—
+2K111675VU C*Pod Intervertebral Body Fusion DeviceTheken Spine, LLC201162—
+3K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+3K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc.20260—
+3K241738PYXIS 3D Titanium Cervical Cage systemGS Medical Co., Ltd.20241—
+3K240699SCARLET® AC-TiSpineart SA20240—
+3K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+3K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—
+3K231252Ventana™ L Spinal SystemSpinal Elements, Inc.20231—
+3K222833Ventana™ C Spinal SystemSpinal Elements, Inc.20234—
+3K223868PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.20232—
+3K230583Tryptik TiSpineart SA20231—
+3K221447Southern Anterior Screw Fixated Cage (SASCA)Southern Medical (Pty), Ltd.20220—
+3K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+3K213118Dakota ALIF SystemPrecision Spine, Inc.20220—
+3K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+3K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+3K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+3K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+3K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+3K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+3K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+3K203444BEE HA CageNGMedical GmbH20211—
+3K200458Tailored-C Cervical Interbody Fusion SystemBespoke Technologies20203—
+3K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+3K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+3K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+3K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+3K201646Shoreline ACS (Anterior Cervical System)SeaSpine Orthopedics Corporation202020—
+3K201506Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical…Meditech Spine, LLC20200—
+3K201605EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular…Eit Emerging Implant Technologies GmbH2020130—
+3K191906MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed…MiRus, LLC20206—
+3K191134IB3D AlifMedicrea International SA20191—
+3K190680Favo S-TlifSilony Medical GmbH20190—
+3K182608Oyster ACIF CageSilony Medical GmbH20190—
+3K181644EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH2018141—
+3K181483Tranquil Interbody SystemNexus Spine, LLC20186—
+3K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+3K172587Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markersMedacta International S.A.20170—
+3K142744Mecta-C TiPEEKMedacta International201512—
+3K132483Innesis Peek Cervical CageBk Meditech, Co., Ltd.20140—
+4K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+4K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+4K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+4K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+4K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+4K250560BEE HANGMedical GmbH20250—
+4K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+4K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+4K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+4K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+4K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+4K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+4K243188Cylox® STSignus Medizintechnik GmbH20250—
+4K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+4K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+4K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+4K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+4K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+4K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+4K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+4K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+4K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+4K230872Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction…Shanghai Sanyou Medical Co, Ltd.20231—