STALIF X

Intervertebral Fusion Device With Integrated Fixation, Lumbar

CENTINEL SPINE INC.

The following data is part of a premarket notification filed by Centinel Spine Inc. with the FDA for Stalif X.

Pre-market Notification Details

• Device ID: K130461
• 510k Number: K130461
• Device Name: STALIF X
• Classification: Intervertebral Fusion Device With Integrated Fixation, Lumbar
• Applicant: CENTINEL SPINE INC. 31 H STREET NW 12TH FLOOR Washington, DC 20005
• Contact: Justin Eggleton
• Correspondent: Justin Eggleton; CENTINEL SPINE INC. 31 H STREET NW 12TH FLOOR Washington, DC 20005
• Product Code: OVD
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-02-22
• Decision Date: 2013-08-28
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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