FRACTURE/RECONSTRUCTION SYSTEM (TRAUMAONE)


Device Classification Name

plate, bone

510(k) Number K081067
Device Name FRACTURE/RECONSTRUCTION SYSTEM (TRAUMAONE)
Applicant
BIOMET MICROFIXATION, INC.
1520 tradeport dr.
jacksonville, 
FL 
32218

Applicant Contact kim reed
Correspondent
BIOMET MICROFIXATION, INC.
1520 tradeport dr.
jacksonville, 
FL 
32218

Correspodent Contact kim reed
Regulation Number 872.4760
Classification Product Code
JEY  
Date Received 04/15/2008
Decision Date 05/09/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No