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FDA 510(k)

OSSIOfiber® Compression Staple

K-Number: K233302 · 2023-11-16

ApplicantOSSIO , Ltd.
Decision Date2023-11-16
Product CodeMNU
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OSSIOfiber® Compression 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 2023-11-16 under 510(k) number K233302. 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® Compression Staple?

OSSIOfiber® Compression Staple is a medical device that received FDA 510(k) clearance on 2023-11-16. The listed applicant is OSSIO , Ltd.. The 510(k) number is K233302.

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

OSSIOfiber® Compression Staple received FDA 510(k) clearance on 2023-11-16, under 510(k) number K233302.

Who is the listed applicant for OSSIOfiber® Compression 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® Compression Staple?

The FDA product code for OSSIOfiber® Compression 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 NailK254055OSSIOfiber® Suture AnchorK252022OSSIOfiber® Interference ScrewK251309OSSIOfiber® Suture AnchorK243760OSSIOfiber® Suture Anchor 2.5-3.5 mmK241932OSSIOfiber® Compression Staple

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Related Devices (Code: MNU)

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.

K241932OSSIOfiber® Compression StapleOSSIO , Ltd.K212594OSSIOfiber® 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.

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