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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 the device name listed in this FDA 510(k) record. The listed applicant is Colorado Therapeutics, LLC. It received FDA 510(k) clearance on 2016-10-20 under 510(k) 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. The listed applicant is Colorado Therapeutics, LLC. The 510(k) number is K160181.

When did COLORADO THERAPEUTICS XENOGRAFT IMPLANT receive FDA 510(k) clearance?

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

Who is the listed applicant for COLORADO THERAPEUTICS XENOGRAFT IMPLANT?

The FDA 510(k) record lists Colorado Therapeutics, LLC as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Colorado Therapeutics, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K172937Colorado Therapeutics Xenograft Implant

Related Devices (Code: FTM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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