FDA 510(k) Application Details - K061698

Device Classification Name Prosthesis, Hip, Cement Restrictor

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510(K) Number K061698
Device Name Prosthesis, Hip, Cement Restrictor
Applicant LIFE SPINE
2400 HASSELL ROAD
SUITE 370
HOFFMAN ESTATES, IL 60195 US
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Contact ERIN MALLOY
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Regulation Number 878.3300

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Classification Product Code JDK
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Date Received 06/16/2006
Decision Date 07/12/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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