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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 a medical device manufactured by Bioventus, LLC. It received FDA 510(k) clearance on 2024-06-25 under approval 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. It is manufactured by Bioventus, LLC. The 510(k) number is K233368.

When was Allograft Delivery Device (OFAC-C) approved by the FDA?

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

What company makes Allograft Delivery Device (OFAC-C)?

Allograft Delivery Device (OFAC-C) is manufactured by Bioventus, LLC.

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

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

Related Clinical Trials

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Related PubMed Literature

PMID: 41967377 Governing the rise of AI in healthcare: A comparative governance document and implementation implications across five jurisdictions. Social science & medicine (1982) (2026) PMID: 41251011 Effectivity of the Dehydrated Human Amnion/Chorion Membrane Allograft for Diabetic Foot Ulcers in Japan: A Case Series. International wound journal (2025) PMID: 40553217 Device reps in theatre: blurred boundaries or regulatory gaps? Monash bioethics review (2025) PMID: 39855465 [Review of practices concerning the delivery of an international implant card following the implantation of a medical device]. Annales pharmaceutiques francaises (2025)

Other Devices by Bioventus, LLC

K162860MCS Bone Graft K233490SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE Putty K243782StimTrial Neuromodulation System K243678TalisMann Neuromodulation System PMA P900009Stimulator, bone growth, non-invasive PMA P170007Acid, hyaluronic, intraarticular

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Related Devices (Code: FMF)

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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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