510(k) Report

Devices descending from K080758

1,091 later devices reach Avs PL Peek Spacers, Models 48351 and 48353 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+6K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+6K250521NanoBone® SBX Putty ; NanoBone® QDBiocomposites, Ltd.20250—
+6K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+6K250556Porous Biologic ScaffoldVentris Medical20250—
+6K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+6K250605EVOL® ha – Hyper C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20250—
+6K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+6K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+6K243706Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft GranulesMedtronic Sofamor Danek, Inc.20250—
+6K241167BioSphere Putty; BioSphere MIS PuttySynergy Biomedical20240—
+6K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+6K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+6K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+6K242299NovaBone Putty - Synthetic Bioactive Bone GraftNovabone Products, LLC20241—
+6K242273Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation202402
+6K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+6K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+6K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+6K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+6K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+6K240699SCARLET® AC-TiSpineart SA20240—
+6K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+6K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+6K234119UniSpace® Stand-Alone C CageInnosys Co., Ltd.20241—
+6K240442MagnetOs PuttyKuros Biosciences B.V20243—
+6K240507NuVasive AttraX ScaffoldNuvasive, Inc.20240—
+6K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+6K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+6K240458Synthetic Bone PuttyVentris Medical20242—
+6K240459Cerament Bone Void FillerBonesupport AB20240—
+6K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+6K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+6K232347MagnetOs GranulesKuros Biosciences B.V20242—
+6K233744Curiteva Porous PEEK Lumbar Interbody Fusion SystemCuriteva, Inc.20242—
+6K233607MagnetOs Easypack PuttyKuros Biosciences B.V20232—
+6K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+6K233490SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyBioventus, LLC20232—
+6K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+6K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+6K233191TotalTi ACDF by SAGICOSpinal Analytics & Geometrical Implant Co, LLC20230—
+6K233245MagnetOs Flex MatrixKuros Biosciences B.V20230—
+6K230927OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20231—
+6K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+6K232123MectaLIF Anterior Lag ExtensionMedacta International S.A.20231—
+6K231899HAtetracell™-C Titanium Cervical IBF SystemInnovasis, Inc.20232—
+6K232173Ascend VBR System, Ascend NanoTec VBR SystemAlphatec Spine, Inc.20230—
+6K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+6K231076VariLift®-C Interbody Fusion SystemWenzel Spine, Inc.20234—
+6K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+6K232315Catalyst Bone Void FillerOssdsign AB20237—
+6K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+6K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+6K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+6K221138Titus Titanium Cervical by SAGICOSagico VA USA, LLC20231—
+6K231808QUASAR Standalone ACIF SystemGS Medical Co., Ltd.20230—
+6K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+6K231252Ventana™ L Spinal SystemSpinal Elements, Inc.20231—
+6K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…Gbs Commonwealth Co., Ltd.20233—
+6K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+6K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+6K222004INTEGRATE -C Interbody Fusion SystemHappe Spine20236—
+6K223868PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.20232—
+6K223326Axiom PSR SystemRestor3D202301
+6K230026SqualeImplanet, S.A.20230—
+6K230583Tryptik TiSpineart SA20231—
+6K223418DeGen Impulse AM™ SystemDegen Medical20236—
+6K223231Ti-Largo Cervical Interbody SystemFlospine20230—
+6K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+6K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+6K221266Cervical Spine Truss System (CSTS) Interbody Fusion Device4Web Medical, Inc.20233—
+6K223140AEON-C™ Stand Alone SystemDio Medical, Inc.20222—
+6K223065Adcura® Sagittae® Lateral Lumbar Interbody Fusion DevicesAdcura, Inc.20220—
+6K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+6K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+6K212450Keos Anterior Cervical Interbody Fusion Device SystemKeos20220—
+6K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+6K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+6K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+6K212266FIX-C PEEK Anterior Cervical Interbody SystemJeil Medical Corporation20217—
+6K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+6K212653Catalyft LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.202127
+6K210590Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20210—
+6K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+6K211388Lateral Spine Truss System (LSTS) Interbody Fusion Device4Web Medical, Inc.20210—
+6K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc.20210—
+6K211306LabyrinthZavation Medical Products, LLC20213—
+6K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+6K200919Idys ALIF 3DTiClariance20210—
+6K202032Idys LLIF 3DTiClariance, Sas20210—
+6K203342CONSTRUX Mini Ti Spacer SystemOrthofix, Inc.202191
+6K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+6K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+6K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC20204—
+6K201287Impulse Interbody Fusion SystemDegen Medical20208—
+6K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+6K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+6K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+6K202949CONSTRUX Mini PEEK Spacer SystemOrthofix, Inc.20206—
+6K202666CONSTRUX Mini PTC Spacer SystemOrthofix, Inc.202010—