CarriGen PF— 510(k) K182107

Substantially Equivalent

Etex Corporation

FDA 510(k) clearance K182107 for CarriGen PF, Substantially Equivalent on 2018-08-31. Applicant: Etex Corporation.

Clearance details

Applicant: Etex Corporation
Product code: Code MQV
Advisory panel: Orthopedic
Date received: 2018-08-03
Decision date: 2018-08-31
Decision: Substantially Equivalent
Clearance type: Special
Location: Cambridge, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MQV

product code MQV

Death: 6
Injury: 435
Total: 441

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.