OSA RIGID INTERNAL FIXATION SYSTEM


Device Classification Name

plate, bone

510(k) Number K021618
Device Name OSA RIGID INTERNAL FIXATION SYSTEM
Original Applicant
OSTEOMED CORP.
3750 realty rd.
addison, 
TX 
75001 -4311

Original Contact dawn t holdeman
Regulation Number 872.4760
Classification Product Code
JEY  
Date Received 05/16/2002
Decision Date 08/08/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No