SFC— 510(k) K951303

Substantially Equivalent

Medpac

FDA 510(k) clearance K951303 for SFC, Substantially Equivalent on 1995-06-27. Applicant: Medpac.

Clearance details

Applicant: Medpac
Product code: Code HWC
Advisory panel: Orthopedic
Date received: 1995-03-22
Decision date: 1995-06-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Valencia, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HWC

product code HWC

Death: 20
Injury: 15,910
Malfunction: 8,192
Other: 1
Total: 24,123

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.