STALIF C(R)

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(r).

Pre-market Notification Details

• Device ID: K133200
• 510k Number: K133200
• Device Name: STALIF C(R)
• 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: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-10-17
• Decision Date: 2014-05-08
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00815101028583	K133200	000
00815101028729	K133200	000
00815101028736	K133200	000
00815101028743	K133200	000
00815101028750	K133200	000
00815101028767	K133200	000
00815101028774	K133200	000
00815101028781	K133200	000
00815101028798	K133200	000
00815101028804	K133200	000
00815101028811	K133200	000
00815101028828	K133200	000
00815101028712	K133200	000
00815101028705	K133200	000
00815101028590	K133200	000
00815101028606	K133200	000
00815101028613	K133200	000
00815101028620	K133200	000
00815101028637	K133200	000
00815101028644	K133200	000
00815101028651	K133200	000
00815101028668	K133200	000
00815101028675	K133200	000
00815101028682	K133200	000
00815101028699	K133200	000
00815101028835	K133200	000
00815101028842	K133200	000
00815101028989	K133200	000
00815101028996	K133200	000
00815101029009	K133200	000
00815101029016	K133200	000
00815101029023	K133200	000
00815101029030	K133200	000
00815101029047	K133200	000
00815101029108	K133200	000
00815101029115	K133200	000
00815101029122	K133200	000
00815101029139	K133200	000
00815101028972	K133200	000
00815101028965	K133200	000
00815101028859	K133200	000
00815101028866	K133200	000
00815101028873	K133200	000
00815101028880	K133200	000
00815101028897	K133200	000
00815101028903	K133200	000
00815101028910	K133200	000
00815101028927	K133200	000
00815101028934	K133200	000
00815101028941	K133200	000
00815101028958	K133200	000
00815101029146	K133200	000