OSSIOfiber® Threaded Trimmable Fixation Nail
K-Number: K254077 · 2026-05-01
ApplicantOSSIO , Ltd.
Decision Date2026-05-01
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
OSSIOfiber® Threaded Trimmable Fixation Nail is a medical device manufactured by OSSIO , Ltd.. It received FDA 510(k) clearance on 2026-05-01 under approval number K254077. 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 Nail?
OSSIOfiber® Threaded Trimmable Fixation Nail is a medical device that received FDA 510(k) clearance on 2026-05-01. It is manufactured by OSSIO , Ltd.. The 510(k) number is K254077.
When was OSSIOfiber® Threaded Trimmable Fixation Nail approved by the FDA?
OSSIOfiber® Threaded Trimmable Fixation Nail received FDA 510(k) clearance on 2026-05-01, under approval number K254077.
What company makes OSSIOfiber® Threaded Trimmable Fixation Nail?
OSSIOfiber® Threaded Trimmable Fixation Nail is manufactured by OSSIO , Ltd..
What is the FDA product code for OSSIOfiber® Threaded Trimmable Fixation Nail?
The FDA product code for OSSIOfiber® Threaded Trimmable Fixation Nail is HWC. This falls under the Cardiovascular category.
Related Devices (Code: HWC)
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.