NextAR™ Spine Platform

Orthopedic Stereotaxic Instrument

Medacta International, SA

The following data is part of a premarket notification filed by Medacta International, Sa with the FDA for Nextar™ Spine Platform.

Pre-market Notification Details

• Device ID: K210859
• 510k Number: K210859
• Device Name: NextAR™ Spine Platform
• Classification: Orthopedic Stereotaxic Instrument
• Applicant: Medacta International, SA Strada Regina Castel San Pietro, CH Ch-6874
• Contact: Stefano Baj
• Correspondent: Chris Lussier; Medacta USA 3973 Delp Street Memphis, TN 38118
• Product Code: OLO
• Subsequent Product Code: JWH
• Subsequent Product Code: PBF
• CFR Regulation Number: 882.4560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-03-23
• Decision Date: 2021-11-05

NIH GUDID Devices

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