SYNTHES CRANIOFACIAL PLATE AND SCREW SYSTEM


Device Classification Name

plate, bone

510(k) Number K080331
Device Name SYNTHES CRANIOFACIAL PLATE AND SCREW SYSTEM
Applicant
SYNTHES (USA)
1302 wrights lane east
west chester, 
PA 
19380

Applicant Contact amnon talmor
Correspondent
SYNTHES (USA)
1302 wrights lane east
west chester, 
PA 
19380

Correspodent Contact amnon talmor
Regulation Number 872.4760
Classification Product Code
JEY  
Date Received 02/06/2008
Decision Date 04/30/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No