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FDA 510(k)

OSSIOfiber Cannulated Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, Cannulated Design

K-Number: K203465 · 2021-01-06

ApplicantOSSIO , Ltd.
Decision Date2021-01-06
Product CodeHTY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OSSIOfiber Cannulated Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, Cannulated Design is the device name listed in this FDA 510(k) record. The listed applicant is OSSIO , Ltd.. It received FDA 510(k) clearance on 2021-01-06 under 510(k) number K203465. 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 Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, Cannulated Design?

OSSIOfiber Cannulated Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, Cannulated Design is a medical device that received FDA 510(k) clearance on 2021-01-06. The listed applicant is OSSIO , Ltd.. The 510(k) number is K203465.

When did OSSIOfiber Cannulated Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, Cannulated Design receive FDA 510(k) clearance?

OSSIOfiber Cannulated Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, Cannulated Design received FDA 510(k) clearance on 2021-01-06, under 510(k) number K203465.

Who is the listed applicant for OSSIOfiber Cannulated Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, Cannulated Design?

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 Cannulated Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, Cannulated Design?

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

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Other records listing OSSIO , Ltd. as applicant

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Related Devices (Code: HTY)

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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