510(k) Report

Devices descending from K041888

1,586 later devices reach Curved Peek Tetris Spinal Implant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K102402Solus Anterior Lumbar Interbody Fusion (Alif) Spinal Spacer SystemAlphatec Spine, Inc.20111121
+3K102597Piccolo Composite Plate SystemN.M.B. Medical Applications, Ltd.201115—
+3K102369Piccolo Composite Nailing SystemN.M.B. Medical Applications, Ltd.2011161
+3K101812Construx Mini Peek Spacer SystemOrthofix, Inc.2010291—
+3K101310VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC2010480—
+3K100889Endoskeleton TCTitan Spine, LLC2010455—
+3K100544Impix Lumbar Interbody DeviceMedicrea Technologies201001
+3K100802Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc.2010461—
+3K100497Quantum IM Composite Nailing System (Quantum Nailing System)N.M.B. Medical Applications, Ltd.201029—
+3K092211Chesapeake Spinal SystemK2m, Inc.2010450—
+3K082698Aleutian Ibf SystemK2m, Inc.2009662—
+3K081880Atlas Spine SpacerAtlas Spine, Inc.20080—
+3K081849Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc.20087531
+3K081564Creaspine Supstance Vertebral Body Replacement System Line ExtensionCreaspine20080—
+3K071726ZUMASeaspine, Inc.200712—
+3K072120Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc.20071,405—
+3K071497Atlas Spine Vertebral Body ReplacementAtlas Spine, Inc.20070—
+3K063399Aleutian Spacer SystemK2m, Inc.2007663—
+3K060350Construx PL/TL Peek Partial VBR SystemBlackstone Medical, Inc.2006754—
+4K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+4K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+4K252219Cervical Interbody and VBR Fusion SystemSync Surgical20260—
+4K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+4K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+4K251016MectaLIF 3D MetalMedacta International S.A.20250—
+4K243188Cylox® STSignus Medizintechnik GmbH20250—
+4K2316554CIS® Chiron Spinal Fixation SystemSolco Biomedical Co., Ltd.20240—
+4K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+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—
+4K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+4K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+4K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—
+4K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+4K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+4K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+4K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…Gbs Commonwealth Co., Ltd.20233—
+4K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+4K223412LumiVy™ Lumbar IBF SystemVy Spine, LLC20235—
+4K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+4K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+4K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+4K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+4K212831MectaLIF ExtensionMedacta International S.A.20211—
+4K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+4K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+4K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+4K202637F3D Corpectomy SystemCorelink, LLC20201—
+4K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+4K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+4K201769Cavetto [MAX] Cervical Cage SystemNeurostructures, Inc.20200—
+4K201585Monterey AL Interbody SystemStryker Corporation202044
+4K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+4K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+4K193457AUDERE Lumbar Spacer SystemMet One Technologies20201—
+4K192897icotec Cervical CageIcotec AG20201—
+4K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+4K193378CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd.20202—
+4K193412NEXXT MATRIXX SystemNexxt Spine, LLC20201—
+4K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+4K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+4K1803473d CageFims Co., Ltd.20190—
+4K190684LxHA PEEK Lateral IBF SystemInnovasis, Inc.20190—
+4K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+4K183092Kuros TLIF CageKuros Biosciences B.V20190—
+4K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC20195—
+4K181589Curiteva Lumbar Interbody Fusion SystemCuriteva, LLC20186—
+4K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC20189—
+4K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+4K181590Neurostructures Cavetto® [MAX] Cervical Cage SystemNeurostructures, Inc.20180—
+4K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+4K181818Scarlet AL-TSpineart201864—
+4K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+4K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+4K181261Curiteva Cervical Interbody Fusion SystemCuriteva, LLC20184—
+4K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20186—
+4K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+4K180056Genesys Spine AIS-C Cervical Anchored Interbody SystemGenesys Spine201818—
+4K173652Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20170—
+4K172032Modulift Vertebral Body Replacement (VBR) SystemAesculap Implants Systems, Inc.201746—
+4K173022SeaSpine Ventura NanoMetalene SystemSeaSpine Orthopedics Corporation20170—
+4K171914Cortina™ Lumbar Cage SystemNeurostructures, Inc.20172—
+4K171489Acapella Cervical Spacer SystemChoicespine, LP201739—
+4K172587Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markersMedacta International S.A.20170—
+4K171140Matrixx SystemNexxt Spine, LLC2017145—
+4K170503EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH20171992
+4K171046SeaSpine Cambria SystemSeaSpine Orthopedics Corporation201762—
+4K170844Gemini-C Hybrid Cervical Interbody SystemOsseus Fusion Systems, LLC20170—
+4K170401Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20173—
+4K170243LOSPA IS TLIF & DLIF CagesCorentec Co., Ltd.20170—
+4K162693VertebraLINK Fusion PlatformFacetlink Dba Linkspine20170—
+4K163364MOJAVE Expandable Interbody SystemK2m201725—
+4K1624024CIS® Marlin ACIF Cage SystemSolco Biomedical Co., Ltd.20171—
+4K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK…Orthofix, Inc.20166—
+4K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc.20166—
+4K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc.20165—
+4K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+4K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine…Choicespine, LP2016161—
+4K162715SeaSpine Spacer System- Hollywood NanoMetalene, Hollywood VI NanoMetalene, Ventura…SeaSpine Orthopedics Corporation2016103—
+4K153665Prow Fusion-LNlt Spine, Ltd.20160—