MODIFICATION TO TENOR SPINAL SYSTEM


Device Classification Name

appliance, fixation, spinal interlaminal

510(k) Number K022191
Device Name MODIFICATION TO TENOR SPINAL SYSTEM
Original Applicant
MEDTRONIC SOFAMOR DANEK, INC.
1800 pyramid place
memphis, 
TN 
38132

Original Contact richard w treharne
Regulation Number 888.3050
Classification Product Code
KWP  
Subsequent Product Code
MNH  
Date Received 07/05/2002
Decision Date 08/28/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No