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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pin, Fixation, Smooth
510(k) Number K160194
Device Name StarFuse Interphalangeal Pin
Applicant
Phalanx Innovations
200 Cobb Pkw N, Bldg. 200, Suite 210
Marietta,  GA  30062
Applicant Contact Daniel Lanois
Correspondent
Wagoner Consulting, LLC
P.O. Box 15729
Wilmington,  NC  28408
Correspondent Contact Cheryl Wagoner
Regulation Number888.3040
Classification Product Code
HTY  
Date Received01/27/2016
Decision Date 04/26/2016
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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