510(k) Report

Devices descending from K030744

1,040 later devices reach Blackstone Surgical Titanium Mesh through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K172888EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH2017159—
+9K172419Velofix™ TLIF CageU&I Corporation20172—
+9K171660Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20174—
+9K160066Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, Inc.20163—
+9K153105MLX™ - Medial Lateral Expandable Lumbar Interbody SystemNu Vasive, Incorporated2016234—
+9K152972Amendia Stand-Alone Cervical SystemAmendia, Inc.201632
+9K152259InFill Interbody Fusion DevicePinnacle Spine Group, LLC20152—
+10K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+10K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+10K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+10K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+10K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+10K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+10K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+10K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+10K241738PYXIS 3D Titanium Cervical Cage systemGS Medical Co., Ltd.20241—
+10K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+10K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+10K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+10K230872Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction…Shanghai Sanyou Medical Co, Ltd.20231—
+10K233084Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT…Gbs Commonwealth Co., Ltd.20232—
+10K222833Ventana™ C Spinal SystemSpinal Elements, Inc.20234—
+10K220449DePuy CONDUIT LLIF SQUID InserterEnztec Limited20220—
+10K212823DePuy CONDUIT LLIF Angled InsertersEnztec Limited20213—
+10K210728CONDUIT InstrumentsMedos International SARL20215—
+10K201024Expandable Titanium PLIF/TLIF SystemSpectrum Spine, LLC20215—
+10K203327VERTACONNECT TLIF CageSignus Medizintechnik20210—
+10K200084Zavation IBF SystemZavation Medical Products, LLC20208—
+10K193172Luna XD Ti Interbody Fusion SystemBenvenue Medical, Inc.20201—
+10K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+10K182608Oyster ACIF CageSilony Medical GmbH20190—
+10K182114FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20196—
+10K181792Duo™ Lumbar Interbody Fusion DeviceSpineology, Inc.20183—
+10K180642Pro-Link® Ti Stand-Alone Cervical Spacer SystemLife Spine, Inc.20182—
+11K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+11K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+11K254017SWINGO-3D Lumbar Cage SystemImplanet20260—
+11K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+11K223671CONDUIT LLIF Straight InsertersEnztec Limited20231—
+12K232014CONDUIT™ ATP InsertersEnztec Limited20230—