SPINAL USA INTERBODY FUSION DEVICE


Device Classification Name

intervertebral fusion device with bone graft, lumbar

510(k) Number K080314
Device Name SPINAL USA INTERBODY FUSION DEVICE
Applicant
SPINAL USA
644 lakeland east dr., ste. a
flowood, 
MS 
39232

Applicant Contact jeffrey johnson
Correspondent
SPINAL USA
644 lakeland east dr., ste. a
flowood, 
MS 
39232

Correspodent Contact jeffrey johnson
Regulation Number 888.3080
Classification Product Code
MAX  
Subsequent Product Codes
KWQ   ODP  
Date Received 02/06/2008
Decision Date 05/13/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No