OsteoCentric Integrated Hip Fastener System

Device, Fixation, Proximal Femoral, Implant

OsteoCentric Technologies D.b.a. OsteoCentric Trauma

The following data is part of a premarket notification filed by Osteocentric Technologies D.b.a. Osteocentric Trauma with the FDA for Osteocentric Integrated Hip Fastener System.

Pre-market Notification Details

Device IDK210247
510k NumberK210247
Device Name:OsteoCentric Integrated Hip Fastener System
ClassificationDevice, Fixation, Proximal Femoral, Implant
Applicant OsteoCentric Technologies D.b.a. OsteoCentric Trauma 75 West 300 North, Suite #150 Logan,  UT  84321
ContactTodd Evans
CorrespondentNathan Wright
Empirical Testing Corp. 4628 Northpark Drive Colorado Springs,  CO  80918
Product CodeJDO  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-29
Decision Date2021-04-30

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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00816950029189 K210247 000
00816950029028 K210247 000

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