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FDA 510(k)

Allograft MIS Delivery System

K-Number: K201338 · 2020-07-13

ApplicantLifenet Health
Decision Date2020-07-13
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Allograft MIS Delivery System is a medical device manufactured by Lifenet Health. It received FDA 510(k) clearance on 2020-07-13 under approval number K201338. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Allograft MIS Delivery System?

Allograft MIS Delivery System is a medical device that received FDA 510(k) clearance on 2020-07-13. It is manufactured by Lifenet Health. The 510(k) number is K201338.

When was Allograft MIS Delivery System approved by the FDA?

Allograft MIS Delivery System received FDA 510(k) clearance on 2020-07-13, under approval number K201338.

What company makes Allograft MIS Delivery System?

Allograft MIS Delivery System is manufactured by Lifenet Health.

What is the FDA product code for Allograft MIS Delivery System?

The FDA product code for Allograft MIS Delivery System is FMF.

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Related PubMed Literature

PMID: 41251011 Effectivity of the Dehydrated Human Amnion/Chorion Membrane Allograft for Diabetic Foot Ulcers in Japan: A Case Series. International wound journal (2025)

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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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