MODIFICATION TO: BIOSORB RESORBABLE VOID FILLER— 510(k) K071155
Substantially EquivalentScience For Biomaterials
FDA 510(k) clearance K071155 for MODIFICATION TO: BIOSORB RESORBABLE VOID FILLER, Substantially Equivalent on 2007-07-03. Applicant: Science For Biomaterials.
Clearance details
- Applicant
- Science For Biomaterials
- Product code
- Code MQV
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lourdes, FR
Adverse 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.