510(k) Report

Devices descending from K150152

10 later devices reach The Octane Straight Intervertebral Fusion Device, Ti Coated through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+1K193172Luna XD Ti Interbody Fusion SystemBenvenue Medical, Inc.20201—
+1K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+2K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+2K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+2K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+3K250769Dakota LP SystemPrecision Spine, Inc.20250—
+3K240699SCARLET® AC-TiSpineart SA20240—
+3K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+4K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—