UNITE BIOMATRIX— 510(k) K112399
Substantially EquivalentSynovis Orthopedic & Woundcare
FDA 510(k) clearance K112399 for UNITE BIOMATRIX, Substantially Equivalent on 2011-09-07. Applicant: Synovis Orthopedic & Woundcare.
Clearance details
- Applicant
- Synovis Orthopedic & Woundcare
- Product code
- Code KGN
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Irvine, CA, US
Adverse events under product code KGN
product code KGN- Other
- 2
- Total
- 2
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.