Signature™ ONE System

Shoulder Arthroplasty Implantation System

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 Signature™ One System.

Pre-market Notification Details

• Device ID: K212560
• 510k Number: K212560
• Device Name: Signature™ ONE System
• Classification: Shoulder Arthroplasty Implantation System
• Applicant: Orthosoft Inc. (d/b/a Zimmer CAS) 75 Queen Street Suite 3300 Montreal, CA H3C 2N6
• Contact: Sankalp Dere
• Correspondent: Sankalp Dere; Orthosoft Inc. (d/b/a Zimmer CAS) 75 Queen Street Suite 3300 Montreal, CA H3C 2N6
• Product Code: QHE
• Subsequent Product Code: KWS
• Subsequent Product Code: KWT
• Subsequent Product Code: MBF
• Subsequent Product Code: PHX
• CFR Regulation Number: 888.3660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-08-13
• Decision Date: 2021-10-12

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00887868522994	K212560	000
00887868522987	K212560	000