XPAND RADIOLUCENT CORPECTOMY SPACER

Spinal Vertebral Body Replacement Device

GLOBUS MEDICAL INC.

The following data is part of a premarket notification filed by Globus Medical Inc. with the FDA for Xpand Radiolucent Corpectomy Spacer.

Pre-market Notification Details

• Device ID: K060665
• 510k Number: K060665
• Device Name: XPAND RADIOLUCENT CORPECTOMY SPACER
• Classification: Spinal Vertebral Body Replacement Device
• Applicant: GLOBUS MEDICAL INC. 303 SCHELL LN. Phoenixville, PA 19460
• Contact: Kelly J Baker
• Correspondent: Kelly J Baker; GLOBUS MEDICAL INC. 303 SCHELL LN. Phoenixville, PA 19460
• Product Code: MQP
• CFR Regulation Number: 888.3060 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-03-14
• Decision Date: 2006-05-10
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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