Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

TiLink-L SI Joint Fusion System

K-Number: K230446 · 2023-06-07

ApplicantSurGenTec, LLC
Decision Date2023-06-07
Product CodeOUR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TiLink-L SI Joint Fusion System is a medical device manufactured by SurGenTec, LLC. It received FDA 510(k) clearance on 2023-06-07 under approval number K230446. 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 TiLink-L SI Joint Fusion System?

TiLink-L SI Joint Fusion System is a medical device that received FDA 510(k) clearance on 2023-06-07. It is manufactured by SurGenTec, LLC. The 510(k) number is K230446.

When was TiLink-L SI Joint Fusion System approved by the FDA?

TiLink-L SI Joint Fusion System received FDA 510(k) clearance on 2023-06-07, under approval number K230446.

What company makes TiLink-L SI Joint Fusion System?

TiLink-L SI Joint Fusion System is manufactured by SurGenTec, LLC.

What is the FDA product code for TiLink-L SI Joint Fusion System?

The FDA product code for TiLink-L 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 SurGenTec, LLC

K170675Graftgun Universal Graft Delivery System K180937Graftgun Universal Graft Delivery System K190163ALARA Neuro Access Kit K200064OsteoFlo NanoPutty-Quadphasic Synthetic Bone Graft K211855Ion Facet Screw System K231716OsteoFlo® HydroPutty™

View all 23 devices →

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.

↑