FDA 510(k) Application Details - K955137

Device Classification Name Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

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510(K) Number K955137
Device Name Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Applicant IMPLANT IDEAS, LLC.
4036 HAGADORN RD.
SUITE B
OKEMOS, MI 48864 US
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Contact BRENDA SPARKS
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Regulation Number 888.3350

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Classification Product Code JDI
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Date Received 11/13/1995
Decision Date 10/10/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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