510(k) Report

Devices descending from K041939

718 later devices reach Blackstone Peek Vertebral Body Replacement System Lordotic Lateral Spacers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K232014CONDUIT™ ATP InsertersEnztec Limited20230—
+10K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+10K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+10K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+10K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+10K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+10K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+10K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+10K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+11K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+11K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+11K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+11K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+11K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+11K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+11K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+12K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+13K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—