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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/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
510(k) Number K111572
Device Name NOVAE SUNFIT TH DUAL MOBILITY ACETABULAR CUP MODEL SUNFIT TH (METAL-BACK), NOVAE E TH DUAL MOBILITY ACETABULAR CUP MODEL
Applicant
SERF
1001 OAKWOOD BLVD.
ROUND ROCK,  TX  78681
Applicant Contact J.D. WEBB
Correspondent
SERF
1001 OAKWOOD BLVD.
ROUND ROCK,  TX  78681
Correspondent Contact J.D. WEBB
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Code
MEH  
Date Received06/06/2011
Decision Date 08/29/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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