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FDA 510(k)

PathLoc-TA Expandable Lumbar Cage System

K-Number: K223474 · 2023-01-13

ApplicantL&K BIOMED Co., Ltd.
Decision Date2023-01-13
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PathLoc-TA Expandable Lumbar Cage System is a medical device manufactured by L&K BIOMED Co., Ltd.. It received FDA 510(k) clearance on 2023-01-13 under approval number K223474. 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 PathLoc-TA Expandable Lumbar Cage System?

PathLoc-TA Expandable Lumbar Cage System is a medical device that received FDA 510(k) clearance on 2023-01-13. It is manufactured by L&K BIOMED Co., Ltd.. The 510(k) number is K223474.

When was PathLoc-TA Expandable Lumbar Cage System approved by the FDA?

PathLoc-TA Expandable Lumbar Cage System received FDA 510(k) clearance on 2023-01-13, under approval number K223474.

What company makes PathLoc-TA Expandable Lumbar Cage System?

PathLoc-TA Expandable Lumbar Cage System is manufactured by L&K BIOMED Co., Ltd..

What is the FDA product code for PathLoc-TA Expandable Lumbar Cage System?

The FDA product code for PathLoc-TA Expandable Lumbar 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 NCT07277803 Device-Based vs Manual Sensory Training in Low Back Pain NOT_YET_RECRUITING NCT06011551 HYDRAFIL-D: HYDRogel Augmentation For Intervertebral Lumbar Discs RECRUITING NCT07494812 Examining the Feasibility of Using Pressure Gradient Regulated Automated Cerebral Spinal Fluid Drainage During External Lumbar Drain Trials NOT_YET_RECRUITING NCT07214844 A Prospective Study to Evaluate the Efficacy of Iovera Lumbar Medial Branch Cryoneurolysis Versus Radiofrequency Ablation for the Treatment of Chronic Low Back Pain RECRUITING

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

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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