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FDA 510(k)

Odys-SI Screw

K-Number: K262522 · 2026-10-15

ApplicantMedyssey Co, Ltd.
Decision Date2026-10-15
Product CodeOUR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Odys-SI Screw is the device name listed in this FDA 510(k) record. The listed applicant is Medyssey Co, Ltd.. It received FDA 510(k) clearance on 2026-10-15 under 510(k) number K262522. The device is classified under product code OUR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Odys-SI Screw?

Odys-SI Screw is a medical device that received FDA 510(k) clearance on 2026-10-15. The listed applicant is Medyssey Co, Ltd.. The 510(k) number is K262522.

When did Odys-SI Screw receive FDA 510(k) clearance?

Odys-SI Screw received FDA 510(k) clearance on 2026-10-15, under 510(k) number K262522.

Who is the listed applicant for Odys-SI Screw?

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

What is the FDA product code for Odys-SI Screw?

The FDA product code for Odys-SI Screw is OUR.

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Other records listing Medyssey Co, Ltd. as applicant

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Related Devices (Code: OUR)

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.

K261381TiLink-L™ SI Joint Fusion SystemSurGenTec, LLCK260477CATAMARAN™ SI Joint Fusion SystemTenon MedicalK253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.K253611Falco Fusion SystemMcnicoll Surgical, Inc.K252834Sacroiliac Joint Truss System (SJTS)4Web MedicalK251365OptumSI Implant SystemSi Solutions, LLC

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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