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FDA 510(k)

PathLoc-SI Joint Fusion System

K-Number: K153656 · 2016-11-14

ApplicantL&K BIOMED Co., Ltd.
Decision Date2016-11-14
Product CodeOUR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PathLoc-SI Joint Fusion System is a medical device manufactured by L&K BIOMED Co., Ltd.. It received FDA 510(k) clearance on 2016-11-14 under approval number K153656. 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 PathLoc-SI Joint Fusion System?

PathLoc-SI Joint Fusion System is a medical device that received FDA 510(k) clearance on 2016-11-14. It is manufactured by L&K BIOMED Co., Ltd.. The 510(k) number is K153656.

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

PathLoc-SI Joint Fusion System received FDA 510(k) clearance on 2016-11-14, under approval number K153656.

What company makes PathLoc-SI Joint Fusion System?

PathLoc-SI Joint Fusion System is manufactured by L&K BIOMED Co., Ltd..

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

The FDA product code for PathLoc-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 L&K BIOMED Co., Ltd.

K162136CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical Fixation System K162801CastleLoc Spinal Fixation System K161766PathLoc-L MIS Spinal System K153439PathLoc-C Posterior Cervical Fixation System K171813OpenLoc-L Spinal Fixation System, LnK Spinal Fixation System K183168OpenLoc-L Spinal Fixation System

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Related Devices (Code: OUR)

K161755Integrity-SI TM Fusion SystemCoorstek Medical 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 K171595M.U.S.T. Sacral Iliac Screw and Pelvic Trauma SystemMedacta International S.A.

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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