FDA 510(k) Application Details - K132496

Device Classification Name Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained

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510(K) Number K132496
Device Name Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained
Applicant ARTHROSURFACE, INC.
28 FORGE PARKWAY
FRANKLIN, MA 02038 US
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Contact DAWN J WILSON
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Regulation Number 000.0000

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Classification Product Code LZJ
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Date Received 08/09/2013
Decision Date 02/26/2014
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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