FDA 510(k) Application Details - K111046

Device Classification Name Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

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510(K) Number K111046
Device Name Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Applicant CORIN USA
10500 UNIVERSITY CENTER DRIVE
SUITE 190
TAMPA, FL 33612 US
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Contact LUCINDA GERBER
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Regulation Number 888.3353

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Classification Product Code LZO
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Date Received 04/15/2011
Decision Date 06/29/2011
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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