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FDA 510(k)

OSSIOfiber® Threaded Trimmable Fixation Nails

K-Number: K233198 · 2024-03-08

ApplicantOSSIO , Ltd.
Decision Date2024-03-08
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OSSIOfiber® Threaded Trimmable Fixation Nails is a medical device manufactured by OSSIO , Ltd.. It received FDA 510(k) clearance on 2024-03-08 under approval number K233198. 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 OSSIOfiber® Threaded Trimmable Fixation Nails?

OSSIOfiber® Threaded Trimmable Fixation Nails is a medical device that received FDA 510(k) clearance on 2024-03-08. It is manufactured by OSSIO , Ltd.. The 510(k) number is K233198.

When was OSSIOfiber® Threaded Trimmable Fixation Nails approved by the FDA?

OSSIOfiber® Threaded Trimmable Fixation Nails received FDA 510(k) clearance on 2024-03-08, under approval number K233198.

What company makes OSSIOfiber® Threaded Trimmable Fixation Nails?

OSSIOfiber® Threaded Trimmable Fixation Nails is manufactured by OSSIO , Ltd..

What is the FDA product code for OSSIOfiber® Threaded Trimmable Fixation Nails?

The FDA product code for OSSIOfiber® Threaded Trimmable Fixation Nails is HWC. This falls under the Cardiovascular category.

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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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