MODIFICATION TO CD HORIZON SPINAL SYSTEM

Appliance, Fixation, Spinal Interlaminal

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

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