MODIFICATION TO THEKEN ATOLL CERVICO-THORACIC SYSTEM


Device Classification Name

appliance, fixation, spinal interlaminal

510(k) Number K080790
Device Name MODIFICATION TO THEKEN ATOLL CERVICO-THORACIC SYSTEM
Applicant
THEKEN SPINE LLC
1800 triplett blvd.
akron, 
OH 
44306

Applicant Contact dale davison
Correspondent
THEKEN SPINE LLC
1800 triplett blvd.
akron, 
OH 
44306

Correspodent Contact dale davison
Regulation Number 888.3050
Classification Product Code
KWP  
Subsequent Product Code
MNI  
Date Received 03/20/2008
Decision Date 04/29/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No