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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 K101030
Device Name MODIFICATION TO HBS HEADLESS BONE SCREW
Applicant
Biopro, Inc.
2929 Lapeer Rd.
Port Huron,  MI  48060
Applicant Contact DAVID MRAK
Correspondent
Biopro, Inc.
2929 Lapeer Rd.
Port Huron,  MI  48060
Correspondent Contact DAVID MRAK
Regulation Number888.3040
Classification Product Code
HWC  
Date Received04/13/2010
Decision Date 06/03/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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