BIOPRO GO-EZ SCREW


Device Classification Name

screw, fixation, bone

510(k) Number K081149
Device Name BIOPRO GO-EZ SCREW
Applicant
BIOPRO, INC.
17 seventeenth st.
port huron, 
MI 
48060

Applicant Contact david mrak
Correspondent
BIOPRO, INC.
17 seventeenth st.
port huron, 
MI 
48060

Correspodent Contact david mrak
Regulation Number 888.3040
Classification Product Code
HWC  
Date Received 04/22/2008
Decision Date 08/05/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No