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FDA 510(k)

Talos® Lumbar (HA) PEEK IBF Devices

K-Number: K170395 · 2017-06-02

ApplicantMeditech Spine, LLC
Decision Date2017-06-02
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Talos® Lumbar (HA) PEEK IBF Devices is a medical device manufactured by Meditech Spine, LLC. It received FDA 510(k) clearance on 2017-06-02 under approval number K170395. 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 Talos® Lumbar (HA) PEEK IBF Devices?

Talos® Lumbar (HA) PEEK IBF Devices is a medical device that received FDA 510(k) clearance on 2017-06-02. It is manufactured by Meditech Spine, LLC. The 510(k) number is K170395.

When was Talos® Lumbar (HA) PEEK IBF Devices approved by the FDA?

Talos® Lumbar (HA) PEEK IBF Devices received FDA 510(k) clearance on 2017-06-02, under approval number K170395.

What company makes Talos® Lumbar (HA) PEEK IBF Devices?

Talos® Lumbar (HA) PEEK IBF Devices is manufactured by Meditech Spine, LLC.

What is the FDA product code for Talos® Lumbar (HA) PEEK IBF Devices?

The FDA product code for Talos® Lumbar (HA) PEEK IBF Devices is MAX.

Related PubMed Literature

PMID: 41166829 Assessment of intra-operative impact durability of additively manufactured mock lumbar intervertebral body fusion devices. Journal of biomechanics (2026)

Other Devices by Meditech Spine, LLC

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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

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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