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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 the device name listed in this FDA 510(k) record. The listed applicant is OSSIO , Ltd.. It received FDA 510(k) clearance on 2024-03-08 under 510(k) 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. The listed applicant is OSSIO , Ltd.. The 510(k) number is K233198.

When did OSSIOfiber® Threaded Trimmable Fixation Nails receive FDA 510(k) clearance?

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

Who is the listed applicant for OSSIOfiber® Threaded Trimmable Fixation Nails?

The FDA 510(k) record lists OSSIO , Ltd. as the applicant. This does not by itself establish the device manufacturer.

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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Other records listing OSSIO , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254077OSSIOfiber® Threaded Trimmable Fixation NailK254055OSSIOfiber® Suture AnchorK252022OSSIOfiber® Interference ScrewK251309OSSIOfiber® Suture AnchorK243760OSSIOfiber® Suture Anchor 2.5-3.5 mmK241932OSSIOfiber® Compression Staple

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Related Devices (Code: HWC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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