FDA 510(k) Application Details - K032180

Device Classification Name Prosthesis, Hip, Cement Restrictor

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510(K) Number K032180
Device Name Prosthesis, Hip, Cement Restrictor
Applicant NUVASIVE, INC.
10065 OLD GROVE RD.
SAN DIEGO, CA 92131 US
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Contact LAETITIA BERNARD
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Regulation Number 878.3300

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Classification Product Code JDK
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Date Received 07/17/2003
Decision Date 10/07/2003
Decision SESU - SE - WITH LIMITATIONS
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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