FDA 510(k) Application Details - K030259

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

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510(K) Number K030259
Device Name Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Applicant CENTERPLUS ORTHOPEDICS, INC
9900 SPECTRUM DR.
AUSTIN, TX 78717 US
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Contact AUDREY SWEARINGEN
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Regulation Number 888.3660

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Classification Product Code KWS
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Date Received 01/24/2003
Decision Date 04/24/2003
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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