510(k) Report

Devices descending from K213266

3 later devices reach Inspan ScrewLES Fusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+1K231807primaLOK™ SP Interspinous Fusion SystemWenzel Spine, Inc.20230—
+1K221399ZIP™ MIS Interspinous Fusion SystemAurora Spine, Inc.20220—