Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Morpheus® Moldable; Agilon® Moldable

K-Number: K240621 · 2024-04-30

ApplicantBiogennix, LLC
Decision Date2024-04-30
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Morpheus® Moldable; Agilon® Moldable is a medical device manufactured by Biogennix, LLC. It received FDA 510(k) clearance on 2024-04-30 under approval number K240621. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Morpheus® Moldable; Agilon® Moldable?

Morpheus® Moldable; Agilon® Moldable is a medical device that received FDA 510(k) clearance on 2024-04-30. It is manufactured by Biogennix, LLC. The 510(k) number is K240621.

When was Morpheus® Moldable; Agilon® Moldable approved by the FDA?

Morpheus® Moldable; Agilon® Moldable received FDA 510(k) clearance on 2024-04-30, under approval number K240621.

What company makes Morpheus® Moldable; Agilon® Moldable?

Morpheus® Moldable; Agilon® Moldable is manufactured by Biogennix, LLC.

What is the FDA product code for Morpheus® Moldable; Agilon® Moldable?

The FDA product code for Morpheus® Moldable; Agilon® Moldable is MQV.

Other Devices by Biogennix, LLC

K181337Sypher Spacer System K190371Morpheus-C K193487Agilon Strip K193168Agilon Moldable

Related Devices (Code: MQV)

K160566Cerasorb Ortho FoamCurasan AG K160446MCP Bone PuttyBiostructures, LLC K161351NanoBone SBX PuttyArtoss GmbH K161447HydroSet XTOrthovita, Inc. K152077MaxiGenHans Biomed Corp. K151271BellaFuseHans Biomed Corp.

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.

↑