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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name prosthesis, toe (metatarsophalangeal), joint, metal/polymer, semi-constrained
510(k) Number K132496
Device Name ARTHROSURFACE TOEMOTION
Applicant
ARTHROSURFACE, INC.
28 FORGE PARKWAY
FRANKLIN,  MA  02038
Applicant Contact DAWN J WILSON
Correspondent
ARTHROSURFACE, INC.
28 FORGE PARKWAY
FRANKLIN,  MA  02038
Correspondent Contact DAWN J WILSON
Classification Product Code
LZJ  
Date Received08/09/2013
Decision Date 02/26/2014
Decision Substantially Equivalent (SESE)
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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