ROSA® Knee System

Orthopedic Stereotaxic Instrument

Orthosoft, Inc (d/b/a Zimmer CAS)

The following data is part of a premarket notification filed by Orthosoft, Inc (d/b/a Zimmer Cas) with the FDA for Rosa® Knee System.

Pre-market Notification Details

• Device ID: K213708
• 510k Number: K213708
• Device Name: ROSA® Knee System
• Classification: Orthopedic Stereotaxic Instrument
• Applicant: Orthosoft, Inc (d/b/a Zimmer CAS) 75 Queen St, Suite 3300 Montreal, CA H3c 2n6
• Contact: Paul Hardy
• Correspondent: Paul Hardy; Orthosoft, Inc (d/b/a Zimmer CAS) 75 Queen St, Suite 3300 Montreal, CA H3c 2n6
• Product Code: OLO
• CFR Regulation Number: 882.4560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-11-24
• Decision Date: 2022-04-22