RODIN 3D Resin SPLINT, Hard/Flex— 510(k) K231793
Substantially EquivalentBelport Company, Inc., Gingi-Pak
FDA 510(k) clearance K231793 for RODIN 3D Resin SPLINT, Hard/Flex, Substantially Equivalent on 2024-03-26. Applicant: Belport Company, Inc., Gingi-Pak.
Clearance details
- Applicant
- Belport Company, Inc., Gingi-Pak
- Product code
- Code MQC
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Camarillo, CA, US
Adverse events under product code MQC
product code MQC- Injury
- 377
- Total
- 377
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.