DIVERGENCE Anterior Cervical Fusion System

Intervertebral Fusion Device With Bone Graft, Cervical

MEDTRONIC SOFAMOR DANEK USA, INC

The following data is part of a premarket notification filed by Medtronic Sofamor Danek Usa, Inc with the FDA for Divergence Anterior Cervical Fusion System.

Pre-market Notification Details

• Device ID: K142450
• 510k Number: K142450
• Device Name: DIVERGENCE Anterior Cervical Fusion System
• Classification: Intervertebral Fusion Device With Bone Graft, Cervical
• Applicant: MEDTRONIC SOFAMOR DANEK USA, INC 1800 PYRAMID PLACE Memphis, TN 38132
• Contact: Shweta Sharma
• Correspondent: Shweta Sharma; MEDTRONIC SOFAMOR DANEK USA, INC 1800 PYRAMID PLACE Memphis, TN 38132
• Product Code: ODP
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-09-02
• Decision Date: 2014-10-01
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00763000878115	K142450	000
00643169515963	K142450	000
00643169515970	K142450	000
00643169515987	K142450	000
00643169515994	K142450	000
00643169516007	K142450	000
00643169516014	K142450	000
00643169516021	K142450	000
00643169516038	K142450	000
00643169516045	K142450	000
00643169516052	K142450	000
00643169516069	K142450	000
00643169516076	K142450	000
00643169516083	K142450	000
00643169515956	K142450	000
00643169515949	K142450	000
00763000878122	K142450	000
00763000878139	K142450	000
00763000878146	K142450	000
00763000878153	K142450	000
00763000878160	K142450	000
00763000878177	K142450	000
00763000878184	K142450	000
00763000878191	K142450	000
00763000878764	K142450	000
00763000878771	K142450	000
00763000878788	K142450	000
00643169515925	K142450	000
00643169515932	K142450	000
00643169516090	K142450	000
00643169516106	K142450	000
00643169516267	K142450	000
00643169516274	K142450	000
00643169516281	K142450	000
00643169516298	K142450	000
00643169516304	K142450	000
00643169516311	K142450	000
00643169516328	K142450	000
00643169516335	K142450	000
00643169516342	K142450	000
00643169516359	K142450	000
00643169516366	K142450	000
00643169516373	K142450	000
00643169516380	K142450	000
00643169516250	K142450	000
00643169516243	K142450	000
00643169516113	K142450	000
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00643169516199	K142450	000
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00643169516229	K142450	000
00643169516236	K142450	000
00643169516397	K142450	000