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FDA 510(k)

OpenLoc-L Spinal Fixation System

K-Number: K183168 · 2018-12-11

ApplicantL&K BIOMED Co., Ltd.
Decision Date2018-12-11
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OpenLoc-L Spinal Fixation System is a medical device manufactured by L&K BIOMED Co., Ltd.. It received FDA 510(k) clearance on 2018-12-11 under approval number K183168. 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 OpenLoc-L Spinal Fixation System?

OpenLoc-L Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2018-12-11. It is manufactured by L&K BIOMED Co., Ltd.. The 510(k) number is K183168.

When was OpenLoc-L Spinal Fixation System approved by the FDA?

OpenLoc-L Spinal Fixation System received FDA 510(k) clearance on 2018-12-11, under approval number K183168.

What company makes OpenLoc-L Spinal Fixation System?

OpenLoc-L Spinal Fixation System is manufactured by L&K BIOMED Co., Ltd..

What is the FDA product code for OpenLoc-L Spinal Fixation System?

The FDA product code for OpenLoc-L Spinal Fixation System is NKB.

Related Clinical Trials

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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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