OSTEOMED 2.0 LOCKING PLATES AND SCREWS


Device Classification Name

plate, bone

510(k) Number K030448
Device Name OSTEOMED 2.0 LOCKING PLATES AND SCREWS
Applicant
OSTEOMED L.P.
3885 arapaho rd.
addison, 
TX 
75001

Applicant Contact dawn t holdeman
Correspondent
OSTEOMED L.P.
3885 arapaho rd.
addison, 
TX 
75001

Correspodent Contact dawn t holdeman
Regulation Number 872.4760
Classification Product Code
JEY  
Date Received 02/11/2003
Decision Date 05/09/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No