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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 K992235
Device Name ZYRANOX ZIRCONIA CERAMIC FEMORAL HEADS
Applicant
CORIN U.S.A.
10500 UNIVERSITY CENTER DR.,
SUITE 190
TAMPA,  FL  33612
Applicant Contact CRAIG CORRANCE
Correspondent
CORIN U.S.A.
10500 UNIVERSITY CENTER DR.,
SUITE 190
TAMPA,  FL  33612
Correspondent Contact CRAIG CORRANCE
Regulation Number888.3353
Classification Product Code
LZO  
Date Received07/02/1999
Decision Date 11/23/1999
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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