K151382

Substantially Equivalent

Patient Contoured Implant-PEEK (PCI-PEEK)

Applicant: KLS Martin L.P.
Product code: GXN
Advisory panel: Neurology
Date received: 2015-05-22
Decision date: 2015-11-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jacksonville, FL, US

Adverse events under product code GXN

product code GXN

Injury: 208
Total: 208

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.