510(k) Report

Devices descending from K180352

8 later devices reach 7D Surgical System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K2105557D Surgical System - Drill Guide7D Surgical, Inc.20210—
+1K2019667D Surgical FlashLock 1, 7D Surgical Flex Rod Connector - 5.5 mm - 150 mm, 7D Surgical…7D Surgical, Inc.20200—
+1K1921407D Surgical System7D Surgical, Inc.20193—
+1K191012Navigated Pedicle Access KitIzi Medical Products, LLC20191—
+1K1832767D Surgical System7D Surgical, Inc.20190—
+2K232800Navigation Tracking InstrumentsSI-BONE, Inc.20240—
+2K222753SeaSpine 7D Navigation InstrumentsSeaSpine Orthopedics Corporation20221—
+3K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—