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FDA 510(k)

CATAMARAN™ SI Joint Fusion System

K-Number: K260477 · 2026-04-08

ApplicantTenon Medical
Decision Date2026-04-08
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 2026-04-08 under 510(k) number K260477. 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 2026-04-08. The listed applicant is Tenon Medical. The 510(k) number is K260477.

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

CATAMARAN™ SI Joint Fusion System received FDA 510(k) clearance on 2026-04-08, under 510(k) number K260477.

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.

K250403Catamaran 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.

K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.K253611Falco Fusion SystemMcnicoll Surgical, Inc.K252834Sacroiliac Joint Truss System (SJTS)4Web MedicalK251365OptumSI Implant SystemSi Solutions, LLCK252322SIros-X SystemGenesys SpineK253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.

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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