510(k) Report

Devices descending from K202498

3 later devices reach 4CIS SARA Spine System, 4CIS VERTU Spine System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+1K2326074CIS SARA SPINE SYSTEM, 4CIS VERTU SPINE SYSTEM, 4CIS WILL PEDICLE SCREW SYSTEM, aBle…Solco Biomedical Copany India Private Limited20240—
+2K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—