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FDA 510(k)

T-Rex Standalone ALIF

K-Number: K170855 · 2017-09-07

ApplicantSiats, LLC
Decision Date2017-09-07
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

T-Rex Standalone ALIF is a medical device manufactured by Siats, LLC. It received FDA 510(k) clearance on 2017-09-07 under approval number K170855. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the T-Rex Standalone ALIF?

T-Rex Standalone ALIF is a medical device that received FDA 510(k) clearance on 2017-09-07. It is manufactured by Siats, LLC. The 510(k) number is K170855.

When was T-Rex Standalone ALIF approved by the FDA?

T-Rex Standalone ALIF received FDA 510(k) clearance on 2017-09-07, under approval number K170855.

What company makes T-Rex Standalone ALIF?

T-Rex Standalone ALIF is manufactured by Siats, LLC.

What is the FDA product code for T-Rex Standalone ALIF?

The FDA product code for T-Rex Standalone ALIF is OVD.

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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.

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