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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Nose, Internal
510(k) Number K161548
Device Name Osseointegrated Fixtures
Applicant
SOUTHERN IMPLANTS (PTY) LTD.
1 ALBERT STREET
CENTURION,  ZA 0062
Applicant Contact LAURANDA BREYTENBACH
Correspondent
SMITH ASSOCIATES
1468 HARWELL AVENUE
CROFTON,  MD  21114
Correspondent Contact E.J. SMITH
Regulation Number878.3680
Classification Product Code
FZE  
Date Received06/03/2016
Decision Date 12/01/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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