510(k) Report

Devices descending from K171075

15 later devices reach Calix-C Cervical Interbody Spacer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242303MOD-COrthomod, LLC20260—
+1K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+1K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+1K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+1K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc.201801
+2K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+2K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+2K211306LabyrinthZavation Medical Products, LLC20213—
+3K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+3K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+3K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+4K250769Dakota LP SystemPrecision Spine, Inc.20250—
+4K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+5K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+6K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—