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FDA 510(k)

AccelFix Lumbar Plate System

K-Number: K192481 · 2020-07-28

ApplicantL&K BIOMED Co., Ltd.
Decision Date2020-07-28
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AccelFix Lumbar Plate System is a medical device manufactured by L&K BIOMED Co., Ltd.. It received FDA 510(k) clearance on 2020-07-28 under approval number K192481. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AccelFix Lumbar Plate System?

AccelFix Lumbar Plate System is a medical device that received FDA 510(k) clearance on 2020-07-28. It is manufactured by L&K BIOMED Co., Ltd.. The 510(k) number is K192481.

When was AccelFix Lumbar Plate System approved by the FDA?

AccelFix Lumbar Plate System received FDA 510(k) clearance on 2020-07-28, under approval number K192481.

What company makes AccelFix Lumbar Plate System?

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

What is the FDA product code for AccelFix Lumbar Plate System?

The FDA product code for AccelFix Lumbar Plate System is KWQ.

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 NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION 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

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: KWQ)

K160982Sphynx™Eden Spine, LLC K162638CETRA Anterior Cervical Plate SystemOrthofix, Inc. K162194MEDICREA INTERNATIONAL Anterior Cervical Locking Plate SystemMedicrea International SA K162211AccuFit Lateral Plate SystemPrecision Spine, Inc. K162250FortiBridge Anterior Cervical Plate SystemNanovis Spine, LLC K162664Pyrenees Cervical Plate SystemK2m, 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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