510(k) Report

Devices descending from K083661

757 later devices reach Avs TL Peek Spacers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K211413BEE PLIF CageNGMedical GmbH20211—
+7K210728CONDUIT InstrumentsMedos International SARL20215—
+7K200919Idys ALIF 3DTiClariance20210—
+7K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+7K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+7K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+7K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+7K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+7K201614TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.2020471
+7K200920Idys ALIF ZP 3DTiClariance, Sas20203—
+7K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+7K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+7K192718Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20195—
+7K192047Rampart™ One Lumbar Interbody Fusion SystemSpineology, Inc.20190—
+7K190877Juliet® Ti LL Lumbar Interbody DeviceSpineart201911
+7K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies20180—
+8K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+8K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+8K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+8K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+8K254017SWINGO-3D Lumbar Cage SystemImplanet20260—
+8K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+8K252742Navigated InstrumentsTyber Medical, LLC20251—
+8K252322SIros-X SystemGenesys Spine20250—
+8K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+8K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+8K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+8K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+8K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+8K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+8K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+8K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+8K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+8K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+8K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+8K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+8K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+8K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+8K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+8K223671CONDUIT LLIF Straight InsertersEnztec Limited20231—
+8K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+8K212967AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.20211—
+8K212562Idys-C ZP 3DTiClariance, SA20211—
+8K211306LabyrinthZavation Medical Products, LLC20213—
+8K202032Idys LLIF 3DTiClariance, Sas20210—
+9K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+9K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+9K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+9K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+9K250603AxTiHA® Stand-Alone ALIF SystemInnovasis20250—
+9K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+9K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+9K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+9K240715Idys® C ZP 3DTiClariance20240—
+9K232014CONDUIT™ ATP InsertersEnztec Limited20230—
+10K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+10K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—