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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 the device name listed in this FDA 510(k) record. The listed applicant is Lifenet Health. It received FDA 510(k) clearance on 2020-07-13 under 510(k) 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. The listed applicant is Lifenet Health. The 510(k) number is K201338.

When did Allograft MIS Delivery System receive FDA 510(k) clearance?

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

Who is the listed applicant for Allograft MIS Delivery System?

The FDA 510(k) record lists Lifenet Health as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Lifenet Health 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.

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Related Devices (Code: FMF)

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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