510(k) Report

Devices descending from K223105

5 later devices reach Tesera-K SC System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+1K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+2K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+3K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+4K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—