510(k) Report

Devices descending from K151064

17 later devices reach Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+1K152622Alta ACDF SystemBiomet Spine20160—
+2K242303MOD-COrthomod, LLC20260—
+2K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+2K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+2K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+2K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc.201801
+3K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+3K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+3K211306LabyrinthZavation Medical Products, LLC20213—
+4K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+4K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+4K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+5K250769Dakota LP SystemPrecision Spine, Inc.20250—
+5K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+6K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+7K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—