510(k) Report

Devices descending from K033702

1,036 later devices reach Blackstone Peek Vertebral Body Replacement System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+9K220449DePuy CONDUIT LLIF SQUID InserterEnztec Limited20220—
+9K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+9K212823DePuy CONDUIT LLIF Angled InsertersEnztec Limited20213—
+9K210728CONDUIT InstrumentsMedos International SARL20215—
+9K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+9K200084Zavation IBF SystemZavation Medical Products, LLC20208—
+9K192718Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20195—
+9K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+9K192214CarboClear VBR SystemCarboFix Orthopedics, Ltd.20191—
+9K182608Oyster ACIF CageSilony Medical GmbH20190—
+9K183560Luna 3D GEN2 Interbody Fusion SystemBenvenue Medical, Inc.20192—
+9K181792Duo™ Lumbar Interbody Fusion DeviceSpineology, Inc.20183—
+9K180642Pro-Link® Ti Stand-Alone Cervical Spacer SystemLife Spine, Inc.20182—
+9K172696FORZA® XP Expandable Spacer SystemOrthofix, Inc.201825—
+9K172419Velofix™ TLIF CageU&I Corporation20172—
+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—
+10K254017SWINGO-3D Lumbar Cage SystemImplanet20260—
+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—
+10K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+10K223671CONDUIT LLIF Straight InsertersEnztec Limited20231—
+10K201024Expandable Titanium PLIF/TLIF SystemSpectrum Spine, LLC20215—
+10K203327VERTACONNECT TLIF CageSignus Medizintechnik20210—
+10K193172Luna XD Ti Interbody Fusion SystemBenvenue Medical, Inc.20201—
+10K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+10K182114FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20196—
+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—
+11K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+11K232014CONDUIT™ ATP InsertersEnztec Limited20230—