FDA 510(k)

Tritanium® X TL Expandable Curved Posterior Lumbar Cage

K-Number: K200613 · 2020-04-15

Decision Date2020-04-15

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Tritanium® X TL Expandable Curved Posterior Lumbar Cage is a medical device manufactured by Stryker Corporation. It received FDA 510(k) clearance on 2020-04-15 under approval number K200613. 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® X TL Expandable Curved Posterior Lumbar Cage?

Tritanium® X TL Expandable Curved Posterior Lumbar Cage is a medical device that received FDA 510(k) clearance on 2020-04-15. It is manufactured by Stryker Corporation. The 510(k) number is K200613.

When was Tritanium® X TL Expandable Curved Posterior Lumbar Cage approved by the FDA?

Tritanium® X TL Expandable Curved Posterior Lumbar Cage received FDA 510(k) clearance on 2020-04-15, under approval number K200613.

What company makes Tritanium® X TL Expandable Curved Posterior Lumbar Cage?

Tritanium® X TL Expandable Curved Posterior Lumbar Cage is manufactured by Stryker Corporation.

What is the FDA product code for Tritanium® X TL Expandable Curved Posterior Lumbar Cage?

The FDA product code for Tritanium® X TL Expandable Curved Posterior Lumbar Cage is MAX.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT04823858 3Spine Lumbar Fusion Real World Evidence Study ACTIVE_NOT_RECRUITING

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Related Devices (Code: MAX)

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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.