SYNERGY TISSUE MATRIX— 510(k) K113460
Substantially EquivalentSynovis Orthopedic & Woundcare
FDA 510(k) clearance K113460 for SYNERGY TISSUE MATRIX, Substantially Equivalent on 2012-01-11. Applicant: Synovis Orthopedic & Woundcare.
Clearance details
- Applicant
- Synovis Orthopedic & Woundcare
- Product code
- Code FTM
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
Adverse events under product code FTM
product code FTM- Death
- 17
- Injury
- 2,174
- Total
- 2,191
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.