510(k) Report

Devices descending from K200084

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+1K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+1K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+2K250769Dakota LP SystemPrecision Spine, Inc.20250—
+2K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+3K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+3K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+3K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—