MONDEAL EXTREMITY BONE FIXATION SYSTEM


Device Classification Name

plate, fixation, bone

510(k) Number K072740
Device Name MONDEAL EXTREMITY BONE FIXATION SYSTEM
Applicant
MONDEAL MEDICAL SYSTEMS GMBH
p.o. box 500521
san diego, 
CA 
92150 -0521

Applicant Contact jay evans
Correspondent
MONDEAL MEDICAL SYSTEMS GMBH
p.o. box 500521
san diego, 
CA 
92150 -0521

Correspodent Contact jay evans
Regulation Number 888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received 09/27/2007
Decision Date 11/19/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

Type Traditional
Reviewed by Third Party No

Combination Product

No