FDA 510(k)

CATAMARAN SI Joint Fusion System

K-Number: K260477 · 2026-04-08

Decision Date2026-04-08

Product CodeOUR

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

CATAMARAN SI Joint Fusion System is a medical device manufactured by Tenon Medical. It received FDA 510(k) clearance on 2026-04-08 under approval 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. It is manufactured by Tenon Medical. The 510(k) number is K260477.

When was CATAMARAN SI Joint Fusion System approved by the FDA?

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

What company makes CATAMARAN SI Joint Fusion System?

CATAMARAN SI Joint Fusion System is manufactured by Tenon Medical.

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

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

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT05438719 MOTUS Total Joint Replacement Investigational Device Exemption Study ACTIVE_NOT_RECRUITING NCT07575750 Efficacy of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) in Aromatase Inhibitor-induced Arthralgia (AIA) NOT_YET_RECRUITING NCT07598604 Early Mobilization and Equinus Correction in Spastic Cerebral Palsy NOT_YET_RECRUITING NCT07492797 Accessible Remote Rehabilitation System for Real-Time Biomechanical Monitoring NOT_YET_RECRUITING NCT07589829 The Effects of Kinesio Taping on Hallux Valgus COMPLETED

Related PubMed Literature

PMID: 41839575 A Perspective for Integrating Real-World Evidence Into the Investigational Device Exemption Study Design for Lumbar Total Joint Replacement. International journal of spine surgery (2026)

Other Devices by Tenon Medical

K250403Catamaran SI Joint Fusion System

Related Devices (Code: OUR)

K161755Integrity-SI TM Fusion SystemCoorstek Medical K153656PathLoc-SI Joint Fusion SystemL&K BIOMED Co., Ltd. K161210RIALTO(TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC(TM) Powerease(TM) System, and Medtronic Navigated Manual Reusable Instruments for use with the StealthStation(TM) and IPC(TM) Powerease(TM) SystemsMedtronic Sofamor Danek K160652iFUSE Implant SystemSI-BONE, Inc. K152681iFuse Implant System(R)SI-BONE, Inc. K152237The Entasis Dual-Lead Sacroiliac ImplantCorelink, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.