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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 K190261
Device Name BOSS Toe Fixation System
Applicant
Arthrosurface, Inc.
38 Forge Pkwy.
Franklin,  MA  02038
Applicant Contact Dawn J. Wilson
Correspondent
Arthrosurface, Inc.
38 Forge Pkwy.
Franklin,  MA  02038
Correspondent Contact Dawn J. Wilson
Regulation Number888.3730
Classification Product Code
KWD  
Date Received02/08/2019
Decision Date 08/14/2019
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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