510(k) Report

Devices descending from K980288

959 later devices reach Spine-Tech Silhouette Spinal Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K181883FIREFLY® Midline Navigation GuideMighty Oak Medical, Inc.20184—
+8K181399FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20185—
+8K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+8K181281Altus Spine Pedicle Screw SystemAltus Partners, LLC20181—
+8K181188EVEREST Spinal SystemK2m, Inc.20186—
+8K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…SeaSpine Orthopedics Corporation201859—
+8K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+8K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation201767—
+8K171570Additional VIPER PRIME™ screws with fenestrationsMedos International SARL201720—
+8K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+8K171881JAZZ Passer BandImplanet, S.A.20170—
+8K170730JAZZ System, including JAZZ BandImplanet, S.A.20175—
+8K162575Z-LINKPC SystemZavation, LLC20173—
+8K160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20160—
+8K160003Sniper (R) Spine SystemSpine Wave, Inc.20167—
+8K150918PASS OCT Spinal SystemMedicrea International SA201513—
+8K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.2015961
+8K150254Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)201523
+8K141284Caspian Spinal SystemK2m, Inc.20140—
+8K133374Streamline Oct Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Rti Surgical, I20143—
+8K121725Pioneer Posterior Occipito-Cervico-Thoracic (Oct) SystemPioneer Surgical Technology, Inc.201217—
+8K120998Solstice Cross ConnectorLife Spine20121—
+9K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+9K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+9K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+9K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.20260—
+9K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+9K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+9K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+9K253472FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical20260—
+9K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+9K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+9K251943Spineology Navigation InstrumentsSpineology, Inc.20250—
+9K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+9K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+9K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+9K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+9K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+9K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+9K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+9K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+9K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+9K243908Tiger 2 SystemZavation Medical Products, LLC20251—
+9K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+9K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+9K242899NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20240—
+9K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+9K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+9K242042TriALTIS™ Spine SystemMedos International SARL20241—
+9K241846E3D™-C Interbody SystemEvolution Spine20246—
+9K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+9K240368E3D™-A Interbody SystemEvolution Spine20247—
+9K240685Salvo® Spine SystemSpine Wave, Inc.20242—
+9K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+9K240526POWEReam Xia/SerratoStryker Instruments20240—
+9K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+9K233332Statera-C™ Spinal SystemK&J Consulting Corp.20230—
+9K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+9K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+9K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+9K231275Exceed™ Biplanar Expandable Interbody SystemSpine Wave, Inc.20232—
+9K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+9K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…Gbs Commonwealth Co., Ltd.20233—
+9K230989Rod Registration FrameNu Vasive, Incorporated20230—
+9K222097OLYMPIC Deformity Band SystemAstura Medical20233—
+9K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+9K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+9K223412LumiVy™ Lumbar IBF SystemVy Spine, LLC20235—
+9K223294SpineJack® Expansion KitStryker Instruments20221—
+9K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+9K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+9K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+9K222698CUVIS-spineCurexo, Inc.20220—
+9K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+9K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+9K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+9K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+9K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+9K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+9K202476Salvo® Spine SystemSpine Wave, Inc.20204—
+9K201585Monterey AL Interbody SystemStryker Corporation202044
+9K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+9K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+9K193129Yukon OCT Spinal SystemK2m, Inc.202001
+9K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+9K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+9K182470Plateau Spacer SystemLife Spine20180—
+9K182508Saxxony™ Posterior Cervical Thoracic SystemNexxt Spine, LLC20184—
+9K173522Solanas® Posterior Stabilization SystemAlphatec Spine, Inc.20175—
+9K161498Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20161—
+9K161149PASS OCT Spinal SystemMedicrea International SA20160—
+9K160756PASS OCT Spinal SystemMedicrea International SA20160—
+9K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated201617—
+9K153169PASS OCT Patient Specific RodsMedicrea International20164—
+9K152211PCT SystemCentinel Spine, Inc.20150—
+9K150229SOLSTICE OCT SystemLife Spine, Inc.20150—
+9K132504Tiger Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20132—
+10K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+10K262094E3D™-C Interbody SystemEvolution Spine20260—
+10K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—