MECTALIF TIPEEK

Intervertebral Fusion Device With Bone Graft, Lumbar

MEDACTA INTERNATIONAL

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

Pre-market Notification Details

• Device ID: K133192
• 510k Number: K133192
• Device Name: MECTALIF TIPEEK
• Classification: Intervertebral Fusion Device With Bone Graft, Lumbar
• Applicant: MEDACTA INTERNATIONAL 4725 Calle Quetzal, Unit B Camarillo, CA 93012
• Contact: Adam Gross
• Correspondent: Adam Gross; MEDACTA INTERNATIONAL 4725 Calle Quetzal, Unit B Camarillo, CA 93012
• Product Code: MAX
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-10-17
• Decision Date: 2014-01-30
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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