SIMPLICITY SPINAL SYSTEM


information about

Device Classification Name

appliance, fixation, spinal interlaminal

510(k) Number K002103
Device Name SIMPLICITY SPINAL SYSTEM
Original Applicant
MEDTRONIC SOFAMOR DANEK USA, INC.
1800 pyramid place
memphis, 
TN 
38132

Original Contact richard treharne
Regulation Number 888.3050
Classification Product Code
KWP  
Subsequent Product Codes
KWQ   MNH   MNI  
Date Received 07/12/2000
Decision Date 11/02/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

Type Traditional
Reviewed by Third Party No

Combination Product

No