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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, Hemi-, Phalangeal
510(k) Number K063370
Device Name CAP 7.0MM MTP RESURFACING HEMI-ARTHROPLASTY
Applicant
Arthrosurface, Inc.
28 Forge Pkwy.
Franklin,  MA  02038
Applicant Contact DAWN J WILSON
Correspondent
Arthrosurface, Inc.
28 Forge Pkwy.
Franklin,  MA  02038
Correspondent Contact DAWN J WILSON
Regulation Number888.3730
Classification Product Code
KWD  
Date Received11/08/2006
Decision Date 01/12/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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