K240621
- 510(k) number
- K240621
- Device name
- Morpheus® Moldable; Agilon® Moldable
- Applicant
- Biogennix, LLC CA · US
- Product code
- MQV — Filler, Bone Void, Calcium Compound
- Decision date
- 2024-04-30
- Date received
- 2024-03-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
510(k) Summary (official FDA PDF): K240621.pdf
Official FDA record: K240621
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.