510(k) Report

Devices descending from K181246

22 later devices reach Zavation IBF System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+1K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+1K200084Zavation IBF SystemZavation Medical Products, LLC20208—
+1K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+1K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+1K191339Zavation eZspand Interbody SystemZavation Medical Products, LLC20195—
+1K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+2K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+2K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+2K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+2K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+2K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+2K211306LabyrinthZavation Medical Products, LLC20213—
+3K250769Dakota LP SystemPrecision Spine, Inc.20250—
+3K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+3K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+4K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+4K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+4K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, 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—