ELEVATE Spinal System

Intervertebral Fusion Device With Bone Graft, Lumbar

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 Elevate Spinal System.

Pre-market Notification Details

• Device ID: K142559
• 510k Number: K142559
• Device Name: ELEVATE Spinal System
• Classification: Intervertebral Fusion Device With Bone Graft, Lumbar
• Applicant: Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place Memphis, TN 38132
• Contact: Becky Ronner
• Correspondent: Becky Ronner; Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place Memphis, TN 38132
• Product Code: MAX
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-09-11
• Decision Date: 2015-06-09
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00643169484948	K142559	000
00643169430785	K142559	000
00643169430778	K142559	000
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00643169430730	K142559	000
00643169430723	K142559	000
00643169430716	K142559	000
00643169430709	K142559	000
00643169430693	K142559	000
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00643169430679	K142559	000
00643169430662	K142559	000
00643169430655	K142559	000
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00643169430440	K142559	000
00643169430792	K142559	000
00643169430808	K142559	000
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00643169432192	K142559	000
00643169432185	K142559	000
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00643169430822	K142559	000
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00643169430433	K142559	000