NIM-SPINE

Stimulator, Nerve

MEDTRONIC XOMED

The following data is part of a premarket notification filed by Medtronic Xomed with the FDA for Nim-spine.

Pre-market Notification Details

• Device ID: K031510
• 510k Number: K031510
• Device Name: NIM-SPINE
• Classification: Stimulator, Nerve
• Applicant: MEDTRONIC XOMED 6743 SOUTHPOINT DR. NORTH Jacksonville, FL 32216
• Contact: Martin Sargent
• Correspondent: Robert Mosenkis; CITECH 5200 BUTLER PIKE Plymouth Meeting, PA 19462 -1298
• Product Code: ETN
• Subsequent Product Code: GWF
• Subsequent Product Code: IKN
• CFR Regulation Number: 874.1820 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2003-05-14
• Decision Date: 2003-06-18
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00613994896735	K031510	000
00643169294417	K031510	000
00721902692031	K031510	000
00721902670701	K031510	000
00721902670633	K031510	000
00721902670626	K031510	000
00721902572685	K031510	000
00721902572647	K031510	000
00885074056487	K031510	000
00643169314399	K031510	000
00643169314405	K031510	000
00613994896728	K031510	000
00613994896704	K031510	000
00613994896698	K031510	000
00613994244055	K031510	000
00643169938847	K031510	000
00643169938458	K031510	000
00643169314429	K031510	000
00643169314412	K031510	000
00763000034122	K031510	000