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FDA 510(k)

AccelFix Lumbar Expandable Cage System

K-Number: K231680 · 2023-08-24

ApplicantL&K BIOMED Co., Ltd.
Decision Date2023-08-24
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AccelFix Lumbar Expandable Cage System is a medical device manufactured by L&K BIOMED Co., Ltd.. It received FDA 510(k) clearance on 2023-08-24 under approval number K231680. 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 AccelFix Lumbar Expandable Cage System?

AccelFix Lumbar Expandable Cage System is a medical device that received FDA 510(k) clearance on 2023-08-24. It is manufactured by L&K BIOMED Co., Ltd.. The 510(k) number is K231680.

When was AccelFix Lumbar Expandable Cage System approved by the FDA?

AccelFix Lumbar Expandable Cage System received FDA 510(k) clearance on 2023-08-24, under approval number K231680.

What company makes AccelFix Lumbar Expandable Cage System?

AccelFix Lumbar Expandable Cage System is manufactured by L&K BIOMED Co., Ltd..

What is the FDA product code for AccelFix Lumbar Expandable Cage System?

The FDA product code for AccelFix Lumbar Expandable 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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