OsteoCentric Spine MIS Pedicle Fastener System

Thoracolumbosacral Pedicle Screw System

OsteoCentric Technologies

The following data is part of a premarket notification filed by Osteocentric Technologies with the FDA for Osteocentric Spine Mis Pedicle Fastener System.

Pre-market Notification Details

Device IDK221332
510k NumberK221332
Device Name:OsteoCentric Spine MIS Pedicle Fastener System
ClassificationThoracolumbosacral Pedicle Screw System
Applicant OsteoCentric Technologies 75 West 300 N, Suite 150 Logan,  UT  84321
ContactTodd Evans
CorrespondentRoshana Ahmed
Telos Partners, LLC 2850 Frontier Drive Warsaw,  IN  46582
Product CodeNKB  
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-05-09
Decision Date2022-07-28

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