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FDA 510(k)

OSSIOfiber® Cannulated Trimmable Fixation Nail

K-Number: K230750 · 2023-09-13

ApplicantOSSIO , Ltd.
Decision Date2023-09-13
Product CodeHTY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OSSIOfiber® Cannulated Trimmable Fixation Nail is a medical device manufactured by OSSIO , Ltd.. It received FDA 510(k) clearance on 2023-09-13 under approval number K230750. The device is classified under product code HTY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSSIOfiber® Cannulated Trimmable Fixation Nail?

OSSIOfiber® Cannulated Trimmable Fixation Nail is a medical device that received FDA 510(k) clearance on 2023-09-13. It is manufactured by OSSIO , Ltd.. The 510(k) number is K230750.

When was OSSIOfiber® Cannulated Trimmable Fixation Nail approved by the FDA?

OSSIOfiber® Cannulated Trimmable Fixation Nail received FDA 510(k) clearance on 2023-09-13, under approval number K230750.

What company makes OSSIOfiber® Cannulated Trimmable Fixation Nail?

OSSIOfiber® Cannulated Trimmable Fixation Nail is manufactured by OSSIO , Ltd..

What is the FDA product code for OSSIOfiber® Cannulated Trimmable Fixation Nail?

The FDA product code for OSSIOfiber® Cannulated Trimmable Fixation Nail is HTY.

Related Clinical Trials

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Other Devices by OSSIO , Ltd.

K181180OSSIO™ Pin Product Family K201803OSSIOfiber™ Hammertoe Fixation System/OSSIOfiber™ Hammertoe Fixation Implant K193660OSSIOfiber™ Compression Screws K190652OSSIOfiber™ Hammertoe Fixation System/OSSIOfiber™ Hammertoe Fixation Implant K213596OSSIOfiber Compression Screw, 3.5mm K203465OSSIOfiber Cannulated Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, Cannulated Design

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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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