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FDA 510(k)

Catamaran SI Joint Fusion System

K-Number: K250403 · 2025-03-21

ApplicantTenon Medical
Decision Date2025-03-21
Product CodeOUR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Catamaran SI Joint Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Tenon Medical. It received FDA 510(k) clearance on 2025-03-21 under 510(k) number K250403. 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 Catamaran SI Joint Fusion System?

Catamaran SI Joint Fusion System is a medical device that received FDA 510(k) clearance on 2025-03-21. The listed applicant is Tenon Medical. The 510(k) number is K250403.

When did Catamaran SI Joint Fusion System receive FDA 510(k) clearance?

Catamaran SI Joint Fusion System received FDA 510(k) clearance on 2025-03-21, under 510(k) number K250403.

Who is the listed applicant for Catamaran SI Joint Fusion System?

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

What is the FDA product code for Catamaran SI Joint Fusion System?

The FDA product code for Catamaran SI Joint Fusion System is OUR.

Other records listing Tenon Medical 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.

K260477CATAMARAN™ SI Joint Fusion SystemK231944CATAMARAN SI Joint Fusion SystemK180818Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)

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.

K260477CATAMARAN™ 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, LLCK252322SIros-X SystemGenesys Spine

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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