SPINEVISION LUMIS CANNULATED PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S. PEDICLE SCREW FIXATION SYSTEM— 510(k) K133575

Substantially Equivalent

Spinevision S.A.

FDA 510(k) clearance K133575 for SPINEVISION LUMIS CANNULATED PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S. PEDICLE SCREW FIXATION SYSTEM, Substantially Equivalent on 2014-06-30. Applicant: Spinevision S.A..

Clearance details

Applicant: Spinevision S.A.
Product code: 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

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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.