Frontier Medical Devices Posterior Cable Screw System— 510(k) K151346
Substantially EquivalentFrontier Medical Devices, Inc.
FDA 510(k) clearance K151346 for Frontier Medical Devices Posterior Cable Screw System, Substantially Equivalent on 2015-08-20. Applicant: Frontier Medical Devices, Inc.. Device class: 2.
Clearance details
- Applicant
- Frontier Medical Devices, Inc.
- Product code
- Product 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
- Gwinn, MI, US
Recent devices under product code JDQ
view allMore clearances from Frontier Medical Devices, Inc.
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.