MODIFICATION TO CORAL SPINAL SYSTEM


Device Classification Name

orthosis, spinal pedicle fixation, for degenerative disc disease

510(k) Number K081414
Device Name MODIFICATION TO CORAL SPINAL 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 888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   KWQ   MNH   MNI  
Date Received 05/20/2008
Decision Date 06/17/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No