FDA 510(k)

Keos Lumbar IBFD

K-Number: K160631 · 2016-07-15

ApplicantKeos

Decision Date2016-07-15

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Keos Lumbar IBFD is a medical device manufactured by Keos. It received FDA 510(k) clearance on 2016-07-15 under approval number K160631. 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 Keos Lumbar IBFD?

Keos Lumbar IBFD is a medical device that received FDA 510(k) clearance on 2016-07-15. It is manufactured by Keos. The 510(k) number is K160631.

When was Keos Lumbar IBFD approved by the FDA?

Keos Lumbar IBFD received FDA 510(k) clearance on 2016-07-15, under approval number K160631.

What company makes Keos Lumbar IBFD?

Keos Lumbar IBFD is manufactured by Keos.

What is the FDA product code for Keos Lumbar IBFD?

The FDA product code for Keos Lumbar IBFD is MAX.

Other Devices by Keos

K163386Keos Lumbar IBFD K193174Keos Lumbar IBFD K212450Keos Anterior Cervical Interbody Fusion Device 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.