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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
510(k) Number K955271
Device Name MICRO-SEAL ACETABULAR SYSTEM
Applicant
WHITESIDE INSTRUMENTS
12634 OLIVE BLVD.
ST. LOUIS,  MO  63141
Applicant Contact MICHAEL C WALL
Correspondent
WHITESIDE INSTRUMENTS
12634 OLIVE BLVD.
ST. LOUIS,  MO  63141
Correspondent Contact MICHAEL C WALL
Regulation Number888.3358
Classification Product Code
LPH  
Date Received11/15/1995
Decision Date 01/30/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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