Genex Bone Graft Substitute— 510(k) K212721
Substantially EquivalentBiocomposites, Ltd.
FDA 510(k) clearance K212721 for Genex Bone Graft Substitute, Substantially Equivalent on 2022-02-04. Applicant: Biocomposites, Ltd.. Device class: 2.
Clearance details
- Applicant
- Biocomposites, Ltd.
- Product code
- Code MQV
- Device class
- Class 2
- Regulation
- 21 CFR 888.3045
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Keele, GB
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More clearances from Biocomposites, Ltd.
view allAdverse events under product code MQV
product code MQV- Death
- 6
- Injury
- 435
- Total
- 441
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.