MectaLIF Anterior Stand Alone

Intervertebral Fusion Device With Integrated Fixation, Lumbar

Medacta International SA

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

Pre-market Notification Details

• Device ID: K170455
• 510k Number: K170455
• Device Name: MectaLIF Anterior Stand Alone
• Classification: Intervertebral Fusion Device With Integrated Fixation, Lumbar
• Applicant: Medacta International SA Strada Regina Castel San Pietro, CH Ch-6874
• Contact: Stefano Baj
• Correspondent: Roshana Ahmed; Mapi USA, Inc. 2343 Alexandria Drive, Suite 100 Lexington, KY 40504
• Product Code: OVD
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-02-15
• Decision Date: 2017-03-16
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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