ARCOFIX


Device Classification Name

appliance, fixation, spinal intervertebral body

510(k) Number K080020
Device Name ARCOFIX
Applicant
SYNTHES SPINE CO.LP
1302 wrights lane east
west chester, 
PA 
19380

Applicant Contact kirsten stowell
Correspondent
SYNTHES SPINE CO.LP
1302 wrights lane east
west chester, 
PA 
19380

Correspodent Contact kirsten stowell
Regulation Number 888.3060
Classification Product Code
KWQ  
Date Received 01/03/2008
Decision Date 05/23/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No