510(k) Report

Devices descending from K211111

8 later devices reach SureMAX-SA Cervical Standalone System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+1K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+1K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+2K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+2K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+3K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+4K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+5K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—