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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 K161489
Device Name Syntorr K-wire and Pin System
Applicant
Syntorr, Inc.
1157 Harker Ave.
Palo Alto,  CA  94301
Applicant Contact DANIEL MARTIN
Correspondent
Musculoskeletal Clinical Regulatory Advisers, LLC
1331 H St. NW
12th Floor
Washington,  DC  20005
Correspondent Contact Samuel Pollard
Regulation Number888.3040
Classification Product Code
HTY  
Subsequent Product Code
JDW  
Date Received06/01/2016
Decision Date 09/16/2016
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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