510(k) Report

Devices descending from K180673

7 later devices reach Normandy VBR System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191423Normandy VBR SystemZavation Medical Products, LLC20193—
+1K183071VLIFT-s Vertebral Body Replacement SystemStryker Spine20194—
+2K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+2K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+2K211320CAPRI Corpectomy Cage SystemK2m, Inc.20222—
+3K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+3K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—