AAP CANNULATED SCREW AND DARCO HEADED SCREW


Device Classification Name

screw, fixation, bone

510(k) Number K080101
Device Name AAP CANNULATED SCREW AND DARCO HEADED SCREW
Applicant
AAP IMPLANTATE AG
lorenzweg 5
berlin, 

DE

12099

Applicant Contact marc seegers
Correspondent
AAP IMPLANTATE AG
lorenzweg 5
berlin, 

DE

12099

Correspodent Contact marc seegers
Regulation Number 888.3040
Classification Product Code
HWC  
Date Received 01/14/2008
Decision Date 03/25/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No