510(k) Report

Devices descending from K202398

9 later devices reach Ti3Z Cervical Interbody System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+1K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+2K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+2K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+2K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+3K250769Dakota LP SystemPrecision Spine, Inc.20250—
+3K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+4K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+5K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—