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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K191771
Device Name SECURE Screw
Applicant
A.M. Surgical, Inc.
285 Middle Country Rd., Suite 206
Smithtown,  NY  11787
Applicant Contact Vincent Pascale
Correspondent
A.M. Surgical, Inc.
285 Middle Country Rd., Suite 206
Smithtown,  NY  11787
Correspondent Contact Vincent Pascale
Regulation Number888.3040
Classification Product Code
HWC  
Date Received07/02/2019
Decision Date 10/16/2019
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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