510(k) Report

Devices descending from K180076

4 later devices reach Ti 3Z Interbody System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+2K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+3K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+4K250769Dakota LP SystemPrecision Spine, Inc.20250—