510(k) Report

Devices descending from K070381

25 later devices reach Theken VU Mesh VBR System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+1K172323Omnia Medical VBROmnia Medical, LLC20176—
+1K111294Santorini Spinal SystemK2m, Inc.201218—
+1K072537Creaspine Supstance Vertebral Body Replacement SystemCreaspine Sas20071—
+2K191778Omnia Medical VBROmnia Medical, LLC20195—
+2K171704CAPRI Corpectomy Cage SystemK2m201710—
+2K162133VerteFIT Corpectomy Cage SystemLdr Spine USA, Inc.20170—
+2K170055CAPRI Corpectomy Cage SystemK2m201711—
+2K151481Sahara Stabilization SystemK2m, Inc.20155—
+2K142016CAPRIK2m, Inc.201412—
+2K081564Creaspine Supstance Vertebral Body Replacement System Line ExtensionCreaspine20080—
+3K252219Cervical Interbody and VBR Fusion SystemSync Surgical20260—
+3K202637F3D Corpectomy SystemCorelink, LLC20201—
+3K201585Monterey AL Interbody SystemStryker Corporation202044
+3K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+3K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC20189—
+4K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+4K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+4K230329F3D Interbody SystemCorelink, LLC20230—
+4K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+4K211320CAPRI Corpectomy Cage SystemK2m, Inc.20222—
+4K193412NEXXT MATRIXX SystemNexxt Spine, LLC20201—
+5K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+5K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+5K232481RIGEL™ 3DR Anterior Cervical Corpectomy SystemMiRus, LLC20230—