MEDXPERT P.E.S. (PECTUS EXACVATUM SYSTEM), MEDXPERT STRATOS


Device Classification Name

plate, fixation, bone

510(k) Number K073556
Device Name MEDXPERT P.E.S. (PECTUS EXACVATUM SYSTEM), MEDXPERT STRATOS
Applicant
MEDXPERT GMBH
griesweg 47
muhlheim, baden-wurttemberg, 

DE

78570

Applicant Contact franz menean
Correspondent
MEDXPERT GMBH
griesweg 47
muhlheim, baden-wurttemberg, 

DE

78570

Correspodent Contact franz menean
Regulation Number 888.3030
Classification Product Code
HRS  
Date Received 12/19/2007
Decision Date 06/24/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No