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FDA 510(k)

Allograft Delivery Device (OFAC-C)

K-Number: K233368 · 2024-06-25

ApplicantBioventus, LLC
Decision Date2024-06-25
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Allograft Delivery Device (OFAC-C) is the device name listed in this FDA 510(k) record. The listed applicant is Bioventus, LLC. It received FDA 510(k) clearance on 2024-06-25 under 510(k) number K233368. 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 Delivery Device (OFAC-C)?

Allograft Delivery Device (OFAC-C) is a medical device that received FDA 510(k) clearance on 2024-06-25. The listed applicant is Bioventus, LLC. The 510(k) number is K233368.

When did Allograft Delivery Device (OFAC-C) receive FDA 510(k) clearance?

Allograft Delivery Device (OFAC-C) received FDA 510(k) clearance on 2024-06-25, under 510(k) number K233368.

Who is the listed applicant for Allograft Delivery Device (OFAC-C)?

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

What is the FDA product code for Allograft Delivery Device (OFAC-C)?

The FDA product code for Allograft Delivery Device (OFAC-C) is FMF.

Other records listing Bioventus, LLC as applicant

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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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