M-Vizion Femoral Revision System Extension

Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

Medacta International SA

The following data is part of a premarket notification filed by Medacta International Sa with the FDA for M-vizion Femoral Revision System Extension.

Pre-market Notification Details

• Device ID: K191816
• 510k Number: K191816
• Device Name: M-Vizion Femoral Revision System Extension
• Classification: Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
• 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: LZO
• CFR Regulation Number: 888.3353 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-07-05
• Decision Date: 2020-04-29
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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