FDA 510(k) Application Details - K023531

Device Classification Name Prosthesis, Toe, Constrained, Polymer

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510(K) Number K023531
Device Name Prosthesis, Toe, Constrained, Polymer
Applicant NEXA ORTHOPEDICS, INC.
990 PARK CENTER DR., SUITE H
VISTA, CA 92083 US
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Contact LOUISE M FOCHT
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Regulation Number 888.3720

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Classification Product Code KWH
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Date Received 10/21/2002
Decision Date 01/17/2003
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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