STALIF C

Intervertebral Fusion Device With Integrated Fixation, Cervical

CENTINEL SPINE, INC.

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

Pre-market Notification Details

• Device ID: K120819
• 510k Number: K120819
• Device Name: STALIF C
• Classification: Intervertebral Fusion Device With Integrated Fixation, Cervical
• Applicant: CENTINEL SPINE, INC. 900 AIRPORT RD, STE #3B West Chester, PA 19380
• Contact: John Parry
• Correspondent: John Parry; CENTINEL SPINE, INC. 900 AIRPORT RD, STE #3B West Chester, PA 19380
• Product Code: OVE
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-03-19
• Decision Date: 2012-08-31
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00815101020006	K120819	000
00815101023410	K120819	000
00815101023427	K120819	000
00815101023434	K120819	000
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00815101023571	K120819	000
00815101023588	K120819	000
00815101023595	K120819	000
00815101023601	K120819	000
00815101023618	K120819	000
00815101023625	K120819	000
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00815101023397	K120819	000
00815101020013	K120819	000
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00815101023328	K120819	000
00815101023335	K120819	000
00815101023342	K120819	000
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00815101023878	K120819	000
00815101023885	K120819	000
00815101023892	K120819	000
00815101023908	K120819	000
00815101023915	K120819	000
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00815101023854	K120819	000
00815101023847	K120819	000
00815101023656	K120819	000
00815101023663	K120819	000
00815101023670	K120819	000
00815101023687	K120819	000
00815101023694	K120819	000
00815101023700	K120819	000
00815101023717	K120819	000
00815101023724	K120819	000
00815101023731	K120819	000
00815101023830	K120819	000
00815101023960	K120819	000