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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K021164
Device Name MACROPORE OS TRAUMA
Applicant
MACROPORE BIOSURGERY, INC.
6740 TOP GUN ST.
SAN DIEGO,  CA  92121
Applicant Contact KENNETH K KLEINHENZ
Correspondent
MACROPORE BIOSURGERY, INC.
6740 TOP GUN ST.
SAN DIEGO,  CA  92121
Correspondent Contact KENNETH K KLEINHENZ
Regulation Number888.3030
Classification Product Code
HRS  
Date Received04/11/2002
Decision Date 07/01/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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