510(k) Report

Devices descending from K072729

5 later devices reach Sierra through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112025Sure Lok Mini Posterior Cervical/Upper Thoracic SystemSpinal USA20114—
+2K150851Sure Lok Mini Posterior Cervical/Upper Thoracic SystemPrecision Spine, Inc.20153—
+3K162300Reform® POCT SystemPrecision Spine, Inc.20162—
+4K172495Reform® POCT SystemPrecision Spine, Inc.20181—
+5K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—