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FDA 510(k)

OsteoCentric Bone Plate and Screw System

K-Number: K190430 · 2019-03-22

ApplicantOsteocentric Trauma
Decision Date2019-03-22
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OsteoCentric Bone Plate and Screw System is a medical device manufactured by Osteocentric Trauma. It received FDA 510(k) clearance on 2019-03-22 under approval number K190430. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OsteoCentric Bone Plate and Screw System?

OsteoCentric Bone Plate and Screw System is a medical device that received FDA 510(k) clearance on 2019-03-22. It is manufactured by Osteocentric Trauma. The 510(k) number is K190430.

When was OsteoCentric Bone Plate and Screw System approved by the FDA?

OsteoCentric Bone Plate and Screw System received FDA 510(k) clearance on 2019-03-22, under approval number K190430.

What company makes OsteoCentric Bone Plate and Screw System?

OsteoCentric Bone Plate and Screw System is manufactured by Osteocentric Trauma.

What is the FDA product code for OsteoCentric Bone Plate and Screw System?

The FDA product code for OsteoCentric Bone Plate and Screw System is HWC. This falls under the Cardiovascular category.

Related Clinical Trials

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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