510(k) Report

Devices descending from K173338

15 later devices reach Navigated INFINITY™ Instruments through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253921VERTICALE® Navigation InstrumentsSilony Medical GmbH20260—
+1K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+1K253129Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20250—
+1K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpinecraft, LLC20230—
+1K212023Virage Navigation SystemZimmer Biomet Spine, Inc.20211—
+1K200791Navigation Enabled IntrumentsMedos International SARL20205—
+1K181111Navigated INFINITY InstrumentsMedtronic Sofamor Danek USA, Inc.20182—
+2K233256Robotic Integration InstrumentsDePuy Synthes20240—
+2K233255CROSSNAV Navigation Enabled InstrumentsDePuy Synthes20242—
+2K240647Virage® Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20240—
+2K231527TriALTIS Navigation Enabled InstrumentsMedos International Sàrl20233—
+2K231229S-COMP Reform® POCT Navigation InstrumentsPrecision Spine, Inc.20230—
+2K214059CoreLink Navigation InstrumentsCorelink, LLC20220—
+3K241893CROSSNAV Navigation Enabled Instruments and UNAS Navigation ArraysMedos International SARL20241—
+4K254157CROSSNAV Navigation Enabled Instruments for Disc Preparation and InterbodyMedos International SARL20260—