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FDA 510(k)

SPIRA Open Matrix LLIF

K-Number: K180724 · 2018-06-25

ApplicantCamber Spine Technologies, LLC
Decision Date2018-06-25
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SPIRA Open Matrix LLIF is a medical device manufactured by Camber Spine Technologies, LLC. It received FDA 510(k) clearance on 2018-06-25 under approval number K180724. 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 SPIRA Open Matrix LLIF?

SPIRA Open Matrix LLIF is a medical device that received FDA 510(k) clearance on 2018-06-25. It is manufactured by Camber Spine Technologies, LLC. The 510(k) number is K180724.

When was SPIRA Open Matrix LLIF approved by the FDA?

SPIRA Open Matrix LLIF received FDA 510(k) clearance on 2018-06-25, under approval number K180724.

What company makes SPIRA Open Matrix LLIF?

SPIRA Open Matrix LLIF is manufactured by Camber Spine Technologies, LLC.

What is the FDA product code for SPIRA Open Matrix LLIF?

The FDA product code for SPIRA Open Matrix LLIF is MAX.

Other Devices by Camber Spine Technologies, LLC

K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization System K191584FORTICO Anterior Cervical Fixation System K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar Spacers K203503Camber Sacroiliac (SI) Fixation System K232256Alcantara Thoracolumbar Plate System

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

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

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