FDA 510(k)

Cure Lumbar Plate System

K-Number: K201136 · 2020-05-12

Decision Date2020-05-12

Product CodeKWQ

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Cure Lumbar Plate System is a medical device manufactured by Meditech Spine, LLC. It received FDA 510(k) clearance on 2020-05-12 under approval number K201136. 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 Cure Lumbar Plate System?

Cure Lumbar Plate System is a medical device that received FDA 510(k) clearance on 2020-05-12. It is manufactured by Meditech Spine, LLC. The 510(k) number is K201136.

When was Cure Lumbar Plate System approved by the FDA?

Cure Lumbar Plate System received FDA 510(k) clearance on 2020-05-12, under approval number K201136.

What company makes Cure Lumbar Plate System?

Cure Lumbar Plate System is manufactured by Meditech Spine, LLC.

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

The FDA product code for Cure 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 Meditech Spine, LLC

K160604Cure Anterior Cervical Plate (ACP) System K171538Cure Lumbar Plate System K170395Talos® Lumbar (HA) PEEK IBF Devices K181543Cure OPEL-C Plate System K180090Cure Lumbar Plate System K201506Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical Intervertebral Body Fusion System

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Related Devices (Code: KWQ)

K160982SphynxEden 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

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