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 the device name listed in this FDA 510(k) record. The listed applicant is L&K BIOMED Co., Ltd.. It received FDA 510(k) clearance on 2018-09-11 under 510(k) 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. The listed applicant is L&K BIOMED Co., Ltd.. The 510(k) number is K181380.

When did LnK Lumbar Interbody Fusion Cage System receive FDA 510(k) clearance?

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

Who is the listed applicant for LnK Lumbar Interbody Fusion Cage System?

The FDA 510(k) record lists L&K BIOMED Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07777718Lumbar Fusion With Nanotube Versus Titanium CageNOT_YET_RECRUITING NCT04214535Anterior Cervical Disectomy And Fusion Using The Tritanium® C Anterior Cervical Cage For One Or Two-LevelsACTIVE_NOT_RECRUITING NCT048238583Spine Lumbar Fusion Real World Evidence StudyACTIVE_NOT_RECRUITING NCT05237908Clinical Outcome and Fusion Rate of 3D Printed Interbody Fusion Cages and Titanium Coated PEEK CagesACTIVE_NOT_RECRUITING NCT05438719MOTUS Total Joint Replacement Investigational Device Exemption StudyACTIVE_NOT_RECRUITING NCT05583864Lumbar Fusion With Porous Versus Non-Porous CagesACTIVE_NOT_RECRUITING

Other records listing L&K BIOMED Co., Ltd. as applicant

K260840BluEX Cervical Expandable Cage System K261112CastleLoc-P Anterior Cervical Plate System K261130AccelFix Spinal Fixation System K260448CastleLoc Pectus Bar System K251940PathLoc Lumbar Plate System K251741PathLoc Lumbar Interbody Fusion Cage System

View all 38 devices →

Related Devices (Code: MAX)

K261430TruLift Expandable SystemLife Spine, Inc.K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody SySeaSpine Orthopedics Corporation K253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, 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.