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FDA 510(k)

Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)

K-Number: K180818 · 2018-06-13

ApplicantTenon Medical, Inc.
Decision Date2018-06-13
Product CodeOUR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System) is a medical device manufactured by Tenon Medical, Inc.. It received FDA 510(k) clearance on 2018-06-13 under approval number K180818. 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 Sacroiliac Joint Fixation System (CAT SIJ Fixation System)?

Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System) is a medical device that received FDA 510(k) clearance on 2018-06-13. It is manufactured by Tenon Medical, Inc.. The 510(k) number is K180818.

When was Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System) approved by the FDA?

Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System) received FDA 510(k) clearance on 2018-06-13, under approval number K180818.

What company makes Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)?

Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System) is manufactured by Tenon Medical, Inc..

What is the FDA product code for Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)?

The FDA product code for Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System) is OUR.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07277946 AtraUmatic Laparoscopic HerNia Repair Clinical Investigation to Evaluate the Safety and Performance of The ECLIPSIUM System for Mesh Fixation IDE 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

Other Devices by Tenon Medical, Inc.

K231944CATAMARAN 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

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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