K190376

Substantially Equivalent

PASS LP Spinal System

Applicant: Medicrea International SA
Product code: NKB
Advisory panel: Orthopedic
Date received: 2019-02-19
Decision date: 2019-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rillieux-La-Pape, FR

Adverse events under product code NKB

product code NKB

Death: 27
Injury: 5,033
Malfunction: 4,140
Total: 9,200

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.