OrthoVis Web Portal— 510(k) K151501

Substantially Equivalent

Custom Orthopaedic Solutions, Inc.

FDA 510(k) clearance K151501 for OrthoVis Web Portal, Substantially Equivalent on 2015-10-02. Applicant: Custom Orthopaedic Solutions, Inc..

Clearance details

Applicant: Custom Orthopaedic Solutions, Inc.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2015-06-04
Decision date: 2015-10-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cleveland, OH, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

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.