BARNES FEMORAL LENGTHENING DEVICE— 510(k) K895243

Substantially Equivalent

Piedmont Sports Medicine & Orthopaedic Clinic

FDA 510(k) clearance K895243 for BARNES FEMORAL LENGTHENING DEVICE, Substantially Equivalent on 1990-08-10. Applicant: Piedmont Sports Medicine & Orthopaedic Clinic.

Clearance details

Applicant: Piedmont Sports Medicine & Orthopaedic Clinic
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 1989-08-21
Decision date: 1990-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Macon, GA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

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.