Harvey(R) Surgical Assistant— 510(k) K200892

Substantially Equivalent

Orthalign, Inc.

FDA 510(k) clearance K200892 for Harvey(R) Surgical Assistant, Substantially Equivalent on 2020-06-18. Applicant: Orthalign, Inc..

Clearance details

Applicant: Orthalign, Inc.
Product code: Code OLO
Advisory panel: Neurology
Date received: 2020-04-03
Decision date: 2020-06-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Aliso Viejo, CA, US

Download summary PDF View on FDA.gov ↗

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.