FDA 510(k)

LnK Lumbar Interbody Fusion Cage System

K-Number: K181380 · 2018-09-11

Decision Date2018-09-11

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

LnK Lumbar Interbody Fusion Cage System is a medical device manufactured by L&K BIOMED Co., Ltd.. It received FDA 510(k) clearance on 2018-09-11 under approval number K181380. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LnK Lumbar Interbody Fusion Cage System?

LnK Lumbar Interbody Fusion Cage System is a medical device that received FDA 510(k) clearance on 2018-09-11. It is manufactured by L&K BIOMED Co., Ltd.. The 510(k) number is K181380.

When was LnK Lumbar Interbody Fusion Cage System approved by the FDA?

LnK Lumbar Interbody Fusion Cage System received FDA 510(k) clearance on 2018-09-11, under approval number K181380.

What company makes LnK Lumbar Interbody Fusion Cage System?

LnK Lumbar Interbody Fusion Cage System is manufactured by L&K BIOMED Co., Ltd..

What is the FDA product code for LnK Lumbar Interbody Fusion Cage System?

The FDA product code for LnK Lumbar Interbody Fusion Cage System is MAX.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT05508360 "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2) RECRUITING NCT06462729 LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF) RECRUITING NCT05438719 MOTUS Total Joint Replacement Investigational Device Exemption Study ACTIVE_NOT_RECRUITING NCT04823858 3Spine Lumbar Fusion Real World Evidence Study ACTIVE_NOT_RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION

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) PMID: 38273730 Ten-Year Risk of Recall of Novel Spine Devices. 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: MAX)

K163180Hubble IIOrbbo Surgical, LLC K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK Lateral Interbody Fusion SystemOrthofix, Inc. K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL K162103Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon), Choice Spine Interbody Fusion System (Harrier), Choice Spine Vertebral Body Replacement System (Hawkeye)Choicespine, LP K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc. K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.