SPINEVISION LUMIS(TM) CANNULATED POLYAXIAL PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S.(TM) POLYAXIAL PEDICLE ...— 510(k) K112607

Substantially Equivalent

Spinevision S.A.

FDA 510(k) clearance K112607 for SPINEVISION LUMIS(TM) CANNULATED POLYAXIAL PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S.(TM) POLYAXIAL PEDICLE ..., Substantially Equivalent on 2012-06-07. Applicant: Spinevision S.A..

Clearance details

Applicant: Spinevision S.A.
Product code: Code NKB
Advisory panel: Orthopedic
Date received: 2011-09-07
Decision date: 2012-06-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Douglassville, PA, US

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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.