MectaLIF Anterior Extension

Intervertebral Fusion Device With Integrated Fixation, Lumbar

Medacta International S.A.

The following data is part of a premarket notification filed by Medacta International S.a. with the FDA for Mectalif Anterior Extension.

Pre-market Notification Details

• Device ID: K221545
• 510k Number: K221545
• Device Name: MectaLIF Anterior Extension
• Classification: Intervertebral Fusion Device With Integrated Fixation, Lumbar
• Applicant: Medacta International S.A. Strada Regina Castel San Pietro, CH CH-6874
• Contact: Stefano Baj
• Correspondent: Chris Lussier; Medacta USA 3973 Delp Street Memphis, TN 38118
• Product Code: OVD
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2022-05-27
• Decision Date: 2022-10-24

NIH GUDID Devices

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