510(k) Report

Devices descending from K182848

10 later devices reach ROSA ONE Spine application through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221028SURGIVISIO DeviceEcential Robotics20227—
+1K192173ROSA ONE Spine applicationMedtech S.A20190—
+1K192133Zimmer Biomet Universal Navigation SystemZimmer Biomet Spine, Inc.20190—
+2K231886SURGIVISIO DeviceEcential Robotics20236—
+3K242890SPINEART Navigation Instrument SystemSpineart SA20253—
+3K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+4K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+4K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+4K242933SPINEART Navigation Instrument SystemSpineart SA20252—
+5K254158SPINEART Navigation Instrument SystemSpineart SA20261—