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FDA 510(k)

CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical Fixation System

K-Number: K162136 · 2016-11-03

ApplicantL&K BIOMED Co., Ltd.
Decision Date2016-11-03
Product CodeNKG
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical Fixation System is a medical device manufactured by L&K BIOMED Co., Ltd.. It received FDA 510(k) clearance on 2016-11-03 under approval number K162136. The device is classified under product code NKG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical Fixation System?

CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical Fixation System is a medical device that received FDA 510(k) clearance on 2016-11-03. It is manufactured by L&K BIOMED Co., Ltd.. The 510(k) number is K162136.

When was CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical Fixation System approved by the FDA?

CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical Fixation System received FDA 510(k) clearance on 2016-11-03, under approval number K162136.

What company makes CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical Fixation System?

CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical Fixation System is manufactured by L&K BIOMED Co., Ltd..

What is the FDA product code for CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical Fixation System?

The FDA product code for CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical Fixation System is NKG.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT05391828 Persona MC vs PS RCT With ROSA RECRUITING NCT07277946 AtraUmatic Laparoscopic HerNia Repair Clinical Investigation to Evaluate the Safety and Performance of The ECLIPSIUM System for Mesh Fixation IDE RECRUITING NCT07606729 AI-Driven Programs for Non-specific Chronic Neck Pain ACTIVE_NOT_RECRUITING NCT07606196 The Effect of Otolith Dysfunction and Its Rehabilitation in Vestibular Diseases COMPLETED NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION

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

K153656PathLoc-SI Joint Fusion 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

View all 38 devices →

Related Devices (Code: NKG)

K161032neon3™ universal OCT spinal stabilizationUlrich GmbH & Co. KG K162300Reform® POCT SystemPrecision Spine, Inc. K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc. K161478Xenco Medical Posterior Cervical SystemXenco Medical, LLC K161498Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) K153439PathLoc-C Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.

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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