FDA 510(k)

Tritanium® PL Cage

K-Number: K160955 · 2016-07-21

Decision Date2016-07-21

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Tritanium® PL Cage is a medical device manufactured by Stryker. It received FDA 510(k) clearance on 2016-07-21 under approval number K160955. 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 Tritanium® PL Cage?

Tritanium® PL Cage is a medical device that received FDA 510(k) clearance on 2016-07-21. It is manufactured by Stryker. The 510(k) number is K160955.

When was Tritanium® PL Cage approved by the FDA?

Tritanium® PL Cage received FDA 510(k) clearance on 2016-07-21, under approval number K160955.

What company makes Tritanium® PL Cage?

Tritanium® PL Cage is manufactured by Stryker.

What is the FDA product code for Tritanium® PL Cage?

The FDA product code for Tritanium® PL Cage is MAX.

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Other Devices by Stryker

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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

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