510(k) Report

Devices descending from K120564

16 later devices reach Calypso System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143731IMPLANET Spine System (ISS)Implanet, S.A.20158—
+1K132303Implanet Spine SystemImplanet, S.A.201315—
+2K240392JAZZ Spinal SystemImplanet20241—
+2K182771ISS-JAZZ Screw System and JAZZ CAP SPImplanet, S.A.20195—
+2K162764Jazz Frame SystemImplanet, S.A.20176—
+2K160226JAZZ CLAW System (hooks and rods) and JAZZ CLAW connectorImplanet, S.A.20161—
+3K252437JAZZ Spinal SystemImplanet20250—
+3K230565HILINE™ Fixation SystemGlobus Medical, Inc.20230—
+3K201240Mariner Cap SystemSeaSpine Orthopedics Corporation20200—
+3K191217Jazz PFImplanet, S.A.20190—
+3K171881JAZZ Passer BandImplanet, S.A.20170—
+3K170730JAZZ System, including JAZZ BandImplanet, S.A.20175—
+4K222097OLYMPIC Deformity Band SystemAstura Medical20233—
+5K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+6K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+6K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—