510(k) Report

Devices descending from K042415

28 later devices reach Mendec Spine through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241775XeliteMed VertehighFix High Viscosity Spinal Bone CementXelite Biomed, Ltd.20242—
+1K122175Mendec Spine HV, Mendec Spine HV SystemTecres S.P.A.20131—
+1K063438VspspnTecres S.P.A.20070—
+1K062452Kit Mendec Spine and Delivery SystemTecres S.P.A.200618—
+1K061531Space Cpsxl Bone CementDfine, Inc.20062—
+2K251896XeliteMed SuperM-Fix Spinal Bone CementXelite Biomed, Ltd.20260—
+2K243537XeliteMed VertehighFix High Viscosity Spinal Bone Cement SystemXelite Biomed, Ltd.20250—
+2K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+2K072496Modification to Space Cpsxl Bone CementDfine, Inc.20071—
+2K070527Arcuate Vertebral Augmentation SystemMedtronic Sofamor Danek20071—
+2K063248Arcuate Vertebral Augmentation SystemMedtronic Sofamor Danek200717—
+3K113452Acu-Cut Vertebral Augmentation SystemAscendx Spine, Inc.20120—
+3K090986Stabili Erx Bone Cement, Model 1135,Stabilit Vertebral Augmentation System (for Use W/…Dfine, Inc.20090—
+3K072133Avaflex Vertebral Augmentation NeedleCardinal Health, Inc.20073—
+3K070293Benvenue VCF Osteo Coil SystemBenvenue Medical, Inc.200710—
+4K132817Kiva VCF Treatment SystemBenvenue Medical, Inc.20149—
+4K130402Spider System Kolibri Cement NeedleSintea Plustek, LLC20130—
+4K100479Parallax Contour Vertebral Augmentation DeviceArthrocare Corp.20101—
+5K191709V-STRUT Vertebral ImplantHyprevention Sas20202—
+5K181262SpineJack Expansion KitVexim SA20184—
+5K141141Kiva VCF Treatment SystemBenvenue Medical, Inc.20140—
+5K110183Arthrocare Parallax Contour Vertebral Augmentation DeviceArthrocare Corp.20110—
+6K240084V-STRUT® Vertebral ImplantHyprevention20240—
+6K221697Injection Pin (Kip (02031-02061) (03031-03061))Slk Ortho, LLC20230—
+6K202393SpineJack Expansion KitStryker Corporation20203—
+7K211238SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone…Stryker Instruments20212—
+8K223294SpineJack® Expansion KitStryker Instruments20221—
+9K250637VCFix Spinal SystemAmber Implants20250—