FDA 510(k)

OSSIOfiber® Staple

K-Number: K212594 · 2022-01-21

Decision Date2022-01-21

Product CodeMNU

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

OSSIOfiber® Staple is the device name listed in this FDA 510(k) record. The listed applicant is OSSIO , Ltd.. It received FDA 510(k) clearance on 2022-01-21 under 510(k) number K212594. The device is classified under product code MNU. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSSIOfiber® Staple?

OSSIOfiber® Staple is a medical device that received FDA 510(k) clearance on 2022-01-21. The listed applicant is OSSIO , Ltd.. The 510(k) number is K212594.

When did OSSIOfiber® Staple receive FDA 510(k) clearance?

OSSIOfiber® Staple received FDA 510(k) clearance on 2022-01-21, under 510(k) number K212594.

Who is the listed applicant for OSSIOfiber® Staple?

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® Staple?

The FDA product code for OSSIOfiber® Staple is MNU.

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 Nail K254055OSSIOfiber® Suture Anchor K252022OSSIOfiber® Interference Screw K251309OSSIOfiber® Suture Anchor K243760OSSIOfiber® Suture Anchor 2.5-3.5 mm K241932OSSIOfiber® Compression Staple

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Related Devices (Code: MNU)

K241932OSSIOfiber® Compression StapleOSSIO , Ltd.K233302OSSIOfiber® Compression StapleOSSIO , Ltd.

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.