MODIFICATION TO PROVIDENT HIP SYSTEM— 510(k) K002796

Substantially Equivalent

Stelkast Company

FDA 510(k) clearance K002796 for MODIFICATION TO PROVIDENT HIP SYSTEM, Substantially Equivalent on 2000-09-28. Applicant: Stelkast Company.

Clearance details

Applicant
Stelkast Company
Product code
Code LWJ
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Pittsburgh, PA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code LWJ

product code LWJ
Injury
544
Total
544

Source: openFDA MAUDE database, through . 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.