510(k) Report

Devices descending from K001044

5 later devices reach Acme Spine System - Series 6000, 7000, Monoaxial and Polyaxial Screw System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K102995Talon Spinal SystemSpine36020114—
+2K241494Pantheon Pedicle Screw and Iliac Bolt Fixation SystemPantheon Spinal20241—
+2K152920Savannah-T® Pedicle Screw SystemAmendia, Inc.201601
+2K153152Syzygy Stabilization SystemAmendia, Inc.201602
+3K252219Cervical Interbody and VBR Fusion SystemSync Surgical20260—