510(k) Report

Devices descending from K160528

23 later devices reach ANATOMIC PEEK PTC Cervical Fusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+1K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+1K170550Coveris Cervical Cage SystemCamber Spine Technologies20171—
+2K242303MOD-COrthomod, LLC20260—
+2K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+2K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+2K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+2K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+2K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+2K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+2K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+2K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc.201801
+3K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+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—