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FDA 510(k)

PathLoc-L MIS Spinal System

K-Number: K183117 · 2018-11-15

ApplicantL&K BIOMED Co., Ltd.
Decision Date2018-11-15
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PathLoc-L MIS Spinal System is a medical device manufactured by L&K BIOMED Co., Ltd.. It received FDA 510(k) clearance on 2018-11-15 under approval number K183117. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PathLoc-L MIS Spinal System?

PathLoc-L MIS Spinal System is a medical device that received FDA 510(k) clearance on 2018-11-15. It is manufactured by L&K BIOMED Co., Ltd.. The 510(k) number is K183117.

When was PathLoc-L MIS Spinal System approved by the FDA?

PathLoc-L MIS Spinal System received FDA 510(k) clearance on 2018-11-15, under approval number K183117.

What company makes PathLoc-L MIS Spinal System?

PathLoc-L MIS Spinal System is manufactured by L&K BIOMED Co., Ltd..

What is the FDA product code for PathLoc-L MIS Spinal System?

The FDA product code for PathLoc-L MIS Spinal System is NKB.

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Related PubMed Literature

PMID: 41612341 Brain-computer interface commercialization. Journal of neuroengineering and rehabilitation (2026) PMID: 39726899 How to improve the mechanical safety of a novel spinal implant while saving costs and time. JOR spine (2024)

Other Devices by L&K BIOMED Co., Ltd.

K153656PathLoc-SI Joint Fusion System 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

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Related Devices (Code: NKB)

K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc. K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC K162912VIPER PRIME™ additions to the VIPER® SystemMedos International SARL K162160Preference Elite Pedicle Screw SystemAmedica Corporation K162232MOSS 100 Pedicle Screw SystemBiedermann Motech GmbH & Co. KG K162379CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, 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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