K232650

Substantially Equivalent

KHEIRON® Spinal Fixation System, including patient specific K-ROD

Applicant: S.M.A.I.O
Product code: NKB
Advisory panel: Orthopedic
Date received: 2023-08-31
Decision date: 2023-09-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Saint-Priest, 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.