510(k) Report

Devices descending from P070001

5 later devices reach Prodisc TM-C Total Disc Replacement through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221848prodisc C SK, prodisc C Nova, and prodisc C Vivo InstrumentsCentinel Spine, LLC20224—
+2K262639BAGUERA® C Cervical Disc Surgical InstrumentsSpineart SA20260—
+2K253392Synergy Disc InstrumentsSynergy Spine Solutions, Inc.20260—
+2K242869prodisc® L InstrumentsCentinel Spine, LLC20241—
+3K250554prodisc® L InstrumentsCentinel Spine, LLC20250—