CD HORIZON SPINAL SYSTEM


the company

Device Classification Name

orthosis, spondylolisthesis spinal fixation

510(k) Number K000641
Device Name CD HORIZON SPINAL SYSTEM
Original Applicant
MEDTRONIC SOFAMOR DANEK, INC.
1800 pyramid place
memphis, 
TN 
38132

Original Contact richard w treharne
Regulation Number 888.3070
Classification Product Code
MNH  
Subsequent Product Codes
KWP   KWQ   MNI  
Date Received 02/25/2000
Decision Date 12/22/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

Type Traditional
Reviewed by Third Party No

Combination Product

No