510(k) Report

Devices descending from K162375

21 later devices reach Envision 3D: Image Guidance System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222291Paradigm SystemProprio, Inc.20233—
+1K222355PathKeeper SystemPathkeeper Surgical, Ltd.20230—
+1K222753SeaSpine 7D Navigation InstrumentsSeaSpine Orthopedics Corporation20221—
+1K1810417D Surgical System Cranial Application7D Surgical, Inc.20186—
+1K1803527D Surgical System7D Surgical, Inc.20188—
+2K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+2K243258Paradigm SystemProprio, Inc.20252—
+2K2105557D Surgical System - Drill Guide7D Surgical, Inc.20210—
+2K2019667D Surgical FlashLock 1, 7D Surgical Flex Rod Connector - 5.5 mm - 150 mm, 7D Surgical…7D Surgical, Inc.20200—
+2K1929457D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application7D Surgical, Inc.20195—
+2K1921407D Surgical System7D Surgical, Inc.20193—
+2K191012Navigated Pedicle Access KitIzi Medical Products, LLC20191—
+2K1832767D Surgical System7D Surgical, Inc.20190—
+3K250879Paradigm SystemProprio, Inc.20251—
+3K242480FLASH EVD System (10-0002)7D Surgical ULC20240—
+3K232800Navigation Tracking InstrumentsSI-BONE, Inc.20240—
+3K230661Zeta Cranial Navigation SystemZeta Surgical20233—
+4K252950Paradigm SystemProprio, Inc.20250—
+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—