510(k) Report

Devices descending from K043351

11 later devices reach 4.5MM Bone-Lok Facet Screw, Models TFCD-45-3040S or N; SFCD-45-3040S or N through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082795Single Use Perpos PLS System, 4.5 Bone-Lok PLS ImplantInterventional Spine, Inc.20088—
+1K062391Disposable Posterior Lumbar Stabilization Procedure Kit, Models 9045-01 and 9045-02…Triage Medical, Inc.200691
+1K0519494.5 MM LS Facet Compression Device with Polymer Washer, Model LSPW-45-3040Triage Medical, Inc.20050—
+2K102438Primalok Facet Fixation SystemOsteomed LP201041
+2K090767Perpos FCD-2 System (Single Patient Use), Anchor, StabilizerInterventional Spine, Inc.20093—
+3K240085zLOCK Lumbar Facet Fixation SystemZygofix, Ltd.20242—
+3K110170Raptor Facet Fixation SystemAlphatec Spine, Inc.20110—
+3K101762Viper F2 Facet Fixation SystemDepuy Spine, Inc.20101—
+4K242527The Karma® Fixation SystemSpinal Elements, Inc.20250—
+4K242650zLOCK Lumbar Facet Fixation SystemZygofix, Ltd.20240—
+4K192281AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine…Medos International SARL20190—