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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 K200259
Device Name Headless Compression Screw System
Applicant
Osteocentric Extremities, LLC
5113 Southwest Pkwy., Suite 150
Austin,  TX  78735
Applicant Contact Todd Evans
Correspondent
Empirical Testing Corp
4628 Northpark Dr.
Colorado Springs,  CO  80918
Correspondent Contact Meredith May
Regulation Number888.3040
Classification Product Code
HWC  
Date Received02/03/2020
Decision Date 05/04/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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