KNEEALIGN SYSTEM WITH REFERENCE SENSOR— 510(k) K093998

Name: FDA 510(k) clearance K093998
Creator: U.S. Food and Drug Administration
Published: 2010-03-22

Substantially Equivalent

Orthalign, Inc.

FDA 510(k) clearance K093998 for KNEEALIGN SYSTEM WITH REFERENCE SENSOR, Substantially Equivalent on 2010-03-22. Applicant: Orthalign, Inc.. Device class: 2.

Clearance details

Applicant: Orthalign, Inc.
Product code: Code OLO
Device class: Class 2
Regulation: 21 CFR 882.4560
Advisory panel: Neurology
Date received: 2009-12-28
Decision date: 2010-03-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Newport Beach, CA, US

Download summary PDF View on FDA.gov ↗

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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.