PATRIOT TRANSCONTINENTAL LLIF SPACER

Intervertebral Fusion Device With Bone Graft, Lumbar

GLOBUS MEDICAL, INC.

The following data is part of a premarket notification filed by Globus Medical, Inc. with the FDA for Patriot Transcontinental Llif Spacer.

Pre-market Notification Details

• Device ID: K093242
• 510k Number: K093242
• Device Name: PATRIOT TRANSCONTINENTAL LLIF SPACER
• Classification: Intervertebral Fusion Device With Bone Graft, Lumbar
• Applicant: GLOBUS MEDICAL, INC. 2560 GENERAL ARMISTEAD AVE. VALLEY FORGE BUSINESS CENTER Audubon, PA 19403
• Contact: Kelly J Baker
• Correspondent: Kelly J Baker; GLOBUS MEDICAL, INC. 2560 GENERAL ARMISTEAD AVE. VALLEY FORGE BUSINESS CENTER Audubon, PA 19403
• Product Code: MAX
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-10-15
• Decision Date: 2009-12-23
• Summary: summary

NIH GUDID Devices

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