Sternal Cable System— 510(k) K180582
Substantially EquivalentA & E Medical Corporation
FDA 510(k) clearance K180582 for Sternal Cable System, Substantially Equivalent on 2018-05-31. Applicant: A & E Medical Corporation. Device class: 2.
Clearance details
- Applicant
- A & E Medical Corporation
- Product code
- Code JDQ
- Device class
- Class 2
- Regulation
- 21 CFR 888.3010
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Farmingdale, NJ, US
Recent devices under product code JDQ
view allMore clearances from A & E Medical Corporation
view allAdverse 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.