Thorecon Rigid Fixation System— 510(k) K181607
Substantially EquivalentA & E Medical Corporation
FDA 510(k) clearance K181607 for Thorecon Rigid Fixation System, Substantially Equivalent on 2018-10-12. Applicant: A & E Medical Corporation.
Clearance details
- Applicant
- A & E Medical Corporation
- Product code
- Code JDQ
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Farmingdale, NJ, US
Adverse events under product code JDQ
product code JDQ- Death
- 9
- Injury
- 330
- Total
- 339
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.