K133575

Substantially Equivalent

SPINEVISION LUMIS CANNULATED PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S. PEDICLE SCREW FIXATION SYSTEM

Applicant: Spinevision S.A.
Product code: MNH
Advisory panel: Orthopedic
Date received: 2013-11-20
Decision date: 2014-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Antony Cedex, FR

Adverse events under product code MNH

product code MNH

Injury: 978
Malfunction: 793
Total: 1,771

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.