510(k) Report

Devices descending from K041452

815 later devices reach Modification to Verte-Stack Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K223671CONDUIT LLIF Straight InsertersEnztec Limited20231—
+10K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+10K212358Romero Cervical CageSpineup, Inc.20226—
+10K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+10K212967AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.20211—
+10K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+11K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+11K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+11K250603AxTiHA® Stand-Alone ALIF SystemInnovasis20250—
+11K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+11K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+11K232014CONDUIT™ ATP InsertersEnztec Limited20230—
+11K230026SqualeImplanet, S.A.20230—
+11K211306LabyrinthZavation Medical Products, LLC20213—
+12K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—