Promogran Prisma Collagen Matrix with ORC and Silver— 510(k) K251999
Substantially EquivalentSolventum Germany GmbH
FDA 510(k) clearance K251999 for Promogran Prisma Collagen Matrix with ORC and Silver, Substantially Equivalent on 2026-03-13. Applicant: Solventum Germany GmbH.
Clearance details
- Applicant
- Solventum Germany GmbH
- Product code
- Code FRO
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Kamen, DE
Adverse events under product code FRO
product code FRO- Death
- 30
- Injury
- 653
- Malfunction
- 479
- Other
- 11
- Total
- 1,173
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.