510(k) Report

Devices descending from K112664

37 later devices reach Zavation Ibf Systems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180076Ti 3Z Interbody SystemZavation Medical Products, LLC20184—
+1K122021Sterispine LC CageSafe Orthopaedics20122—
+1K120576Zavation Ibf SystemZavation, LLC201232—
+2K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+2K162206Zavation IBFZavation, LLC201724—
+2K151756Sterispine LC CageSafe Orthopaedics20150—
+2K142392Zavation Posterior LEIFZavation, LLC20150—
+2K142271Zavation Z-Link LumbarZavation, LLC20149—
+2K141005Z-Link CervicalZavation, LLC20144—
+2K133893Sterispine LC CageSafe Orthopaedics20141—
+3K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+3K211501Advantage-C PEEK Cervical lnterbody Fusion DeviceLntelivation, LLC20211—
+3K191339Zavation eZspand Interbody SystemZavation Medical Products, LLC20195—
+3K181246Zavation IBF SystemZavation Medical Products, LLC201822—
+3K152972Amendia Stand-Alone Cervical SystemAmendia, Inc.201632
+4K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+4K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+4K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+4K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+4K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System…Spinal Elements, Inc.20211—
+4K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+4K200084Zavation IBF SystemZavation Medical Products, LLC20208—
+4K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+4K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+4K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+5K250769Dakota LP SystemPrecision Spine, Inc.20250—
+5K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+5K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+5K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+5K211306LabyrinthZavation Medical Products, LLC20213—
+6K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+6K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+6K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+6K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+7K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+8K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+9K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—