JMEA CANNULATED BONE SCREW SYSTEM


Device Classification Name

screw, fixation, bone

510(k) Number K080259
Device Name JMEA CANNULATED BONE SCREW SYSTEM
Applicant
JMEA CORPORATION
1 research court
suite 450
rockville, 
MD 
20850

Applicant Contact sam son
Correspondent
JMEA CORPORATION
1 research court
suite 450
rockville, 
MD 
20850

Correspodent Contact sam son
Regulation Number 888.3040
Classification Product Code
HWC  
Subsequent Product Code
HTN  
Date Received 01/31/2008
Decision Date 08/20/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No