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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thoracolumbosacral Pedicle Screw System
510(k) Number K221332
Device Name OsteoCentric Spine MIS Pedicle Fastener System
Applicant
OsteoCentric Technologies
75 W. 300 N.
Suite 150
Logan,  UT  84321
Applicant Contact Todd Evans
Correspondent
Telos Partners, LLC
2850 Frontier Dr.
Warsaw,  IN  46582
Correspondent Contact Roshana Ahmed
Regulation Number888.3070
Classification Product Code
NKB  
Date Received05/09/2022
Decision Date 07/28/2022
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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