OSTEOMED MODULAR LOCKING FIXATION SYSTEM


Device Classification Name

plate, bone

510(k) Number K080694
Device Name OSTEOMED MODULAR LOCKING FIXATION SYSTEM
Applicant
OSTEOMED L.P.
3885 arapaho rd.
addison, 
TX 
75001

Applicant Contact piedad pena
Correspondent
OSTEOMED L.P.
3885 arapaho rd.
addison, 
TX 
75001

Correspodent Contact piedad pena
Regulation Number 872.4760
Classification Product Code
JEY  
Date Received 03/11/2008
Decision Date 05/15/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No