ROSA® Knee System

Orthopedic Stereotaxic Instrument

Orthosoft D/b/a Zimmer CAS

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

Pre-market Notification Details

• Device ID: K221928
• 510k Number: K221928
• Device Name: ROSA® Knee System
• Classification: Orthopedic Stereotaxic Instrument
• Applicant: Orthosoft D/b/a Zimmer CAS 75 Queen Street, Suite 3300 Montreal, CA H3C 2N6
• Contact: Kavina Veeren
• Correspondent: Kavina Veeren; Orthosoft D/b/a Zimmer CAS 75 Queen Street, 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: 2022-07-01
• Decision Date: 2022-10-04

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00887868552229	K221928	000
00887868552212	K221928	000
00887868552205	K221928	000
00887868552199	K221928	000
00887868552175	K221928	000
00887868552168	K221928	000
00887868552151	K221928	000