MectaLIF Posterior Extension

Intervertebral Fusion Device With Bone Graft, Lumbar

Medacta International SA

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

Pre-market Notification Details

• Device ID: K181970
• 510k Number: K181970
• Device Name: MectaLIF Posterior Extension
• Classification: Intervertebral Fusion Device With Bone Graft, Lumbar
• 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: MAX
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-07-24
• Decision Date: 2018-12-04
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07630040719490	K181970	000
07630040719353	K181970	000
07630040719346	K181970	000
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