SCULPTOR ROBOTIC GUIDANCE ARM (RGA)— 510(k) K121765

Substantially Equivalent

Stanmore Implants Worldwide , Ltd.

FDA 510(k) clearance K121765 for SCULPTOR ROBOTIC GUIDANCE ARM (RGA), Substantially Equivalent on 2013-01-11. Applicant: Stanmore Implants Worldwide , Ltd..

Clearance details

Applicant: Stanmore Implants Worldwide , Ltd.
Product code: Code OLO
Advisory panel: Neurology
Date received: 2012-06-15
Decision date: 2013-01-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, 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.