FLUOROMAP SOFTWARE, 9 FLUORODISC (BELT), 12 FLUORO DISC (BELT), CLOSE TUBE CLIP— 510(k) K103400

Substantially Equivalent

Stryker Corporation

FDA 510(k) clearance K103400 for FLUOROMAP SOFTWARE, 9 FLUORODISC (BELT), 12 FLUORO DISC (BELT), CLOSE TUBE CLIP, Substantially Equivalent on 2011-03-07. Applicant: Stryker Corporation.

Clearance details

Applicant: Stryker Corporation
Product code: Code OLO
Advisory panel: Neurology
Date received: 2010-11-19
Decision date: 2011-03-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Freiburg, Baden-Wuerttemberg, DE

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Adverse events under product code OLO

product code OLO

Death: 11
Injury: 2,799
Malfunction: 11,105
Other: 1
Total: 13,916

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.