Mecta-C Stand Alone

Intervertebral Fusion Device With Integrated Fixation, Cervical

Medacta International SA

The following data is part of a premarket notification filed by Medacta International Sa with the FDA for Mecta-c Stand Alone.

Pre-market Notification Details

• Device ID: K192906
• 510k Number: K192906
• Device Name: Mecta-C Stand Alone
• Classification: Intervertebral Fusion Device With Integrated Fixation, Cervical
• 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: OVE
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-10-15
• Decision Date: 2020-03-04

NIH GUDID Devices

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