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 ID: K210247
• 510k Number: K210247
• Device Name: OsteoCentric Integrated Hip Fastener System
• Classification: Device, Fixation, Proximal Femoral, Implant
• Applicant: OsteoCentric Technologies D.b.a. OsteoCentric Trauma 75 West 300 North, Suite #150 Logan, UT 84321
• Contact: Todd Evans
• Correspondent: Nathan Wright; Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, CO 80918
• Product Code: JDO
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-01-29
• Decision Date: 2021-04-30

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00816950029363	K210247	000
00816950028915	K210247	000
00816950028908	K210247	000
00816950028892	K210247	000
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00816950029332	K210247	000
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00816950029547	K210247	000
00816950028700	K210247	000
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00816950028724	K210247	000
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00816950029431	K210247	000
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00816950029417	K210247	000
00816950029400	K210247	000
00816950029394	K210247	000
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00816950029370	K210247	000