MOTO Partial Knee System

Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer

Medacta International SA

The following data is part of a premarket notification filed by Medacta International Sa with the FDA for Moto Partial Knee System.

Pre-market Notification Details

• Device ID: K183029
• 510k Number: K183029
• Device Name: MOTO Partial Knee System
• Classification: Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer
• 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: HSX
• CFR Regulation Number: 888.3520 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-11-01
• Decision Date: 2019-01-30
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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