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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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
Correspondent Contact DAVID MRAK
Regulation Number888.3040
Classification Product Code
HWC  
Date Received04/22/2008
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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