PATIENT SPECIFIC DISTAL FEMORAL— 510(k) K140898

Substantially Equivalent

Stanmore Implants Worldwide , Ltd.

FDA 510(k) clearance K140898 for PATIENT SPECIFIC DISTAL FEMORAL, Substantially Equivalent on 2015-01-20. Applicant: Stanmore Implants Worldwide , Ltd..

Clearance details

Applicant: Stanmore Implants Worldwide , Ltd.
Product code: Code KRO
Advisory panel: Orthopedic
Date received: 2014-04-08
Decision date: 2015-01-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Plymouth, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KRO

product code KRO

Death: 19
Injury: 4,841
Total: 4,860

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.