TF-II HIP PROSTHESIS— 510(k) K843995

Substantially Equivalent

Dow Corning Corp. Healthcare Industries Materials

FDA 510(k) clearance K843995 for TF-II HIP PROSTHESIS, Substantially Equivalent on 1985-04-23. Applicant: Dow Corning Corp. Healthcare Industries Materials.

Clearance details

Applicant: Dow Corning Corp. Healthcare Industries Materials
Product code: Code KWL
Advisory panel: Orthopedic
Date received: 1984-10-11
Decision date: 1985-04-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: P.O. Box 1767 Midland, MI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KWL

product code KWL

Injury: 523
Total: 523

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.