MIDLINE II TI

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 Midline Ii Ti.

Pre-market Notification Details

• Device ID: K141942
• 510k Number: K141942
• Device Name: MIDLINE II TI
• Classification: Intervertebral Fusion Device With Integrated Fixation, Lumbar
• Applicant: CENTINEL SPINE, INC. 1331 H. ST. NW, 12TH FLOOR Washington, DC 20005
• Contact: Justin Eggleton
• Correspondent: Justin Eggleton; CENTINEL SPINE, INC. 1331 H. ST. 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: 2014-07-17
• Decision Date: 2014-11-07
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00815101021577	K141942	000
00815101021430	K141942	000
00815101021423	K141942	000
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00815101021140	K141942	000
00815101021133	K141942	000
00815101021126	K141942	000
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00815101021201	K141942	000
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00815101021225	K141942	000
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00815101021287	K141942	000
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00815101021249	K141942	000
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00815101021980	K141942	000
00815101021973	K141942	000
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00815101021737	K141942	000
00815101021720	K141942	000
00815101021591	K141942	000