510(k) Report

Devices descending from K101682

8 later devices reach S 100 Pedicle Screw System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201568Calvary Spine Pedicle Screw SystemCalvary Spine, LLC20200—
+1K162764Jazz Frame SystemImplanet, S.A.20176—
+2K171881JAZZ Passer BandImplanet, S.A.20170—
+2K170730JAZZ System, including JAZZ BandImplanet, S.A.20175—
+3K222097OLYMPIC Deformity Band SystemAstura Medical20233—
+4K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+5K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+5K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—