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FDA 510(k)

Alcantara Thoracolumbar Plate System

K-Number: K232256 · 2024-04-16

ApplicantCamber Spine Technologies, LLC
Decision Date2024-04-16
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Alcantara Thoracolumbar Plate System is a medical device manufactured by Camber Spine Technologies, LLC. It received FDA 510(k) clearance on 2024-04-16 under approval number K232256. 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 Alcantara Thoracolumbar Plate System?

Alcantara Thoracolumbar Plate System is a medical device that received FDA 510(k) clearance on 2024-04-16. It is manufactured by Camber Spine Technologies, LLC. The 510(k) number is K232256.

When was Alcantara Thoracolumbar Plate System approved by the FDA?

Alcantara Thoracolumbar Plate System received FDA 510(k) clearance on 2024-04-16, under approval number K232256.

What company makes Alcantara Thoracolumbar Plate System?

Alcantara Thoracolumbar Plate System is manufactured by Camber Spine Technologies, LLC.

What is the FDA product code for Alcantara Thoracolumbar Plate System?

The FDA product code for Alcantara Thoracolumbar Plate System is KWQ.

Related Clinical Trials

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

Other Devices by Camber Spine Technologies, LLC

K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization System K180724SPIRA Open Matrix LLIF K191584FORTICO Anterior Cervical Fixation System K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar Spacers K203503Camber Sacroiliac (SI) Fixation System

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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