510(k) Report

Devices descending from K142024

12 later devices reach Brightmatter Navigation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K1810417D Surgical System Cranial Application7D Surgical, Inc.20186—
+1K160523BrightMatter Guide with BrightMatter PointerSynaptive Medical, Inc.20160—
+1K151156Fiagon Navigation SystemFiagon GmbH20161—
+1K153281BrightMatter Guide with Surface Trace RegistrationSynaptive Medical, Inc.20162Class I
+2K1929457D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application7D Surgical, Inc.20195—
+2K183325Modus NavSynaptive Medical, Inc.20190—
+2K163209Fiagon Navigation SystemFiagon GmbH20170—
+3K242480FLASH EVD System (10-0002)7D Surgical ULC20240—
+3K230661Zeta Cranial Navigation SystemZeta Surgical20233—
+4K233903Zeta Cranial Navigation System (ZNS131-US)Zeta Surgical, Inc.20242—
+5K242351Zeta Cranial Navigation System (ZNS131-US)Zeta Surgical, Inc.20241—
+6K253663Zeta Navigation SystemZeta Surgical, Inc.20260—