Zimmer Biomet Holdings Inc. said its robot-assisted system Rosa was approved by the U.S. Food and Drug Administration for spine surgeries.
The Rosa spine system received FDA's 510(k) clearance, which authorizes Zimmer to market the device as safe and effective, or substantially equivalent, to a legally marketed device.
Zimmer Biomet's Rosa spine system provides surgeons tools and real-time data that help improve implant procedures and instrument placement accuracy.
The FDA has also approved the Warsaw, Ind.-based medical device-maker's Rosa systems for brain and knee surgeries.