510(k) Report

Devices descending from K161407

27 later devices reach Ascential IBD PEEKc Spacer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+1K181246Zavation IBF SystemZavation Medical Products, LLC201822—
+1K163265Kepler IIOrbbo Surgical, LLC20170—
+1K162694Ayers Rock Cervical interbody fusion systemSpineway20170—
+2K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+2K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+2K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+2K200084Zavation IBF SystemZavation Medical Products, LLC20208—
+2K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+2K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+2K191339Zavation eZspand Interbody SystemZavation Medical Products, LLC20195—
+2K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+3K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+3K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+3K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+3K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+3K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+3K211306LabyrinthZavation Medical Products, LLC20213—
+4K250769Dakota LP SystemPrecision Spine, Inc.20250—
+4K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+4K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+5K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+5K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+5K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, 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—