MODIFICATION TO CD HORIZON SPINAL SYSTEM

Appliance, Fixation, Spinal Interlaminal

MEDTRONIC SOFAMOR DANEK

The following data is part of a premarket notification filed by Medtronic Sofamor Danek with the FDA for Modification To Cd Horizon Spinal System.

Pre-market Notification Details

• Device ID: K061579
• 510k Number: K061579
• Device Name: MODIFICATION TO CD HORIZON SPINAL SYSTEM
• Classification: Appliance, Fixation, Spinal Interlaminal
• Applicant: MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis, TN 38132
• Contact: Richard W Treharne
• Correspondent: Richard W Treharne; MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis, TN 38132
• Product Code: KWP
• Subsequent Product Code: KWQ
• Subsequent Product Code: MNH
• Subsequent Product Code: MNI
• Subsequent Product Code: NKB
• Subsequent Product Code: NQP
• CFR Regulation Number: 888.3050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-06-07
• Decision Date: 2006-08-11

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00613994582225	K061579	000
00613994155061	K061579	000
00613994155009	K061579	000
00613994154996	K061579	000
00613994154989	K061579	000
00613994154972	K061579	000
00613994154965	K061579	000
00613994154958	K061579	000
00613994154941	K061579	000
00613994154934	K061579	000
00613994154927	K061579	000
00613994154910	K061579	000
00613994154903	K061579	000
00613994154897	K061579	000
00613994154880	K061579	000
00613994155177	K061579	000
00613994155191	K061579	000
00613994582218	K061579	000
00613994155580	K061579	000
00613994155320	K061579	000
00613994155313	K061579	000
00613994155306	K061579	000
00613994155290	K061579	000
00613994155283	K061579	000
00613994155276	K061579	000
00613994155269	K061579	000
00613994155245	K061579	000
00613994155238	K061579	000
00613994155221	K061579	000
00613994155214	K061579	000
00613994155207	K061579	000
00613994154873	K061579	000