510(k) Report

Devices descending from K022143

968 later devices reach Interpore Cross International Anterior Fixation Device (Afd) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+8K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+8K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+8K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+8K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+8K250603AxTiHA® Stand-Alone ALIF SystemInnovasis20250—
+8K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+8K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+8K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+8K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+8K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+8K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+8K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+8K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—
+8K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+8K231715MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation20240—
+8K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+8K230872Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction…Shanghai Sanyou Medical Co, Ltd.20231—
+8K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+8K233084Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT…Gbs Commonwealth Co., Ltd.20232—
+8K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+8K223412LumiVy™ Lumbar IBF SystemVy Spine, LLC20235—
+8K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+8K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+8K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+8K220449DePuy CONDUIT LLIF SQUID InserterEnztec Limited20220—
+8K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+8K212823DePuy CONDUIT LLIF Angled InsertersEnztec Limited20213—
+8K210728CONDUIT InstrumentsMedos International SARL20215—
+8K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+8K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+8K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+8K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+8K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+8K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+8K201646Shoreline ACS (Anterior Cervical System)SeaSpine Orthopedics Corporation202020—
+8K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+8K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+8K192214CarboClear VBR SystemCarboFix Orthopedics, Ltd.20191—
+8K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+8K183243Velofix TLIF CageU&I Corporation20190—
+8K182584Lucent® XPSpinal Elements, Inc.20183—
+8K181837Spinal Elements Ti-Bond coated devicesSpinal Elements, Inc.201898—
+9K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+9K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+9K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+9K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+9K254017SWINGO-3D Lumbar Cage SystemImplanet20260—
+9K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+9K243188Cylox® STSignus Medizintechnik GmbH20250—
+9K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+9K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+9K234150Lucent® XPSpinal Elements20240—
+9K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+9K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+9K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+9K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+9K223671CONDUIT LLIF Straight InsertersEnztec Limited20231—
+9K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+9K202298Lucent XP, Lucent XP CurvedSpinal Elements, Inc.20202—
+9K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+10K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+10K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+10K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+10K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+10K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+10K232014CONDUIT™ ATP InsertersEnztec Limited20230—
+11K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—