510(k) Report

Devices descending from K082795

8 later devices reach Single Use Perpos PLS System, 4.5 Bone-Lok PLS Implant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K102438Primalok Facet Fixation SystemOsteomed LP201041
+1K090767Perpos FCD-2 System (Single Patient Use), Anchor, StabilizerInterventional Spine, Inc.20093—
+2K240085zLOCK Lumbar Facet Fixation SystemZygofix, Ltd.20242—
+2K110170Raptor Facet Fixation SystemAlphatec Spine, Inc.20110—
+2K101762Viper F2 Facet Fixation SystemDepuy Spine, Inc.20101—
+3K242527The Karma® Fixation SystemSpinal Elements, Inc.20250—
+3K242650zLOCK Lumbar Facet Fixation SystemZygofix, Ltd.20240—
+3K192281AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine…Medos International SARL20190—