510(k) Report

Devices descending from K212811

3 later devices reach Ti3Z Lumbar Interbody System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+2K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+3K250769Dakota LP SystemPrecision Spine, Inc.20250—