K072707

Substantially Equivalent

PATIENT CONTOURED MESH-PEEK (PCM-P)

Applicant: KLS-Martin L.P.
Product code: GXN
Advisory panel: Neurology
Date received: 2007-09-25
Decision date: 2007-12-19
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.