510(k) Report

Devices descending from K221049

6 later devices reach Zavation VariSync Plate System and VariSync Spacer System through their predicates, nearest generation first.

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