510(k) Report

Devices descending from K150395

24 later devices reach Omega LIF System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System…Spinal Elements, Inc.20211—
+1K203254Lucent 3D Spinal SystemSpinal Elements, Inc.20218—
+1K183184FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.201912—
+2K260506Ventana® P/T Lumbar Interbody SystemSpinal Elements, Inc.20260—
+2K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+2K231252Ventana™ L Spinal SystemSpinal Elements, Inc.20231—
+2K222833Ventana™ C Spinal SystemSpinal Elements, Inc.20234—
+2K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+2K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+2K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+2K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+2K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+3K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc.20260—
+3K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+3K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+3K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+3K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+3K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+4K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+4K250769Dakota LP SystemPrecision Spine, Inc.20250—
+4K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+4K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+5K261279DeltaNEC Interbody SystemNexus Spine20260—
+5K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—