510(k) Report

Devices descending from K102458

4 later devices reach 4CIS Solar Spine System and 4CIS Apollon Spine System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K2024984CIS SARA Spine System, 4CIS VERTU Spine SystemSolco Biomedical Company India Private Limited20213—
+2K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+2K2326074CIS SARA SPINE SYSTEM, 4CIS VERTU SPINE SYSTEM, 4CIS WILL PEDICLE SCREW SYSTEM, aBle…Solco Biomedical Copany India Private Limited20240—
+3K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—