OsteoCentric Bone Plate And Screw System

Screw, Fixation, Bone

OsteoCentric Trauma

The following data is part of a premarket notification filed by Osteocentric Trauma with the FDA for Osteocentric Bone Plate And Screw System.

Pre-market Notification Details

• Device ID: K190430
• 510k Number: K190430
• Device Name: OsteoCentric Bone Plate And Screw System
• Classification: Screw, Fixation, Bone
• Applicant: OsteoCentric Trauma 5113 Southwest Pkwy, Ste. 150 Austin, TX 79735
• Contact: Todd Evans
• Correspondent: Meredith Lee May; Empirical Consulting LLC 4628 Northpark Dr Colorado Springs, CO 80918
• Product Code: HWC
• CFR Regulation Number: 888.3040 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-02-22
• Decision Date: 2019-03-22

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00810074309219	K190430	000
00816950027369	K190430	000
00816950027376	K190430	000
00816950027383	K190430	000
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00810074309233	K190430	000
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00816950028014	K190430	000