PASS LP Spinal System, CD Horizon Spinal System— 510(k) K213281

Substantially Equivalent

Medicrea International SA

FDA 510(k) clearance K213281 for PASS LP Spinal System, CD Horizon Spinal System, Substantially Equivalent on 2022-01-05. Applicant: Medicrea International SA.

Clearance details

Applicant: Medicrea International SA
Product code: Code NKB
Advisory panel: Orthopedic
Date received: 2021-10-01
Decision date: 2022-01-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rillieux-La-Pape, FR

Download summary PDF View on FDA.gov ↗

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.