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FDA 510(k)

COLORADO THERAPEUTICS XENOGRAFT IMPLANT

K-Number: K160181 · 2016-10-20

ApplicantColorado Therapeutics, LLC
Decision Date2016-10-20
Product CodeFTM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

COLORADO THERAPEUTICS XENOGRAFT IMPLANT is a medical device manufactured by Colorado Therapeutics, LLC. It received FDA 510(k) clearance on 2016-10-20 under approval number K160181. The device is classified under product code FTM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COLORADO THERAPEUTICS XENOGRAFT IMPLANT?

COLORADO THERAPEUTICS XENOGRAFT IMPLANT is a medical device that received FDA 510(k) clearance on 2016-10-20. It is manufactured by Colorado Therapeutics, LLC. The 510(k) number is K160181.

When was COLORADO THERAPEUTICS XENOGRAFT IMPLANT approved by the FDA?

COLORADO THERAPEUTICS XENOGRAFT IMPLANT received FDA 510(k) clearance on 2016-10-20, under approval number K160181.

What company makes COLORADO THERAPEUTICS XENOGRAFT IMPLANT?

COLORADO THERAPEUTICS XENOGRAFT IMPLANT is manufactured by Colorado Therapeutics, LLC.

What is the FDA product code for COLORADO THERAPEUTICS XENOGRAFT IMPLANT?

The FDA product code for COLORADO THERAPEUTICS XENOGRAFT IMPLANT is FTM.

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Other Devices by Colorado Therapeutics, LLC

K172937Colorado Therapeutics Xenograft Implant

Related Devices (Code: FTM)

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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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