H.N. TOTAL HIP PROSTHESIS— 510(k) K901594

Substantially Equivalent

Med-Tek Corp.

FDA 510(k) clearance K901594 for H.N. TOTAL HIP PROSTHESIS, Substantially Equivalent on 1990-08-03. Applicant: Med-Tek Corp..

Clearance details

Applicant: Med-Tek Corp.
Product code: Code LWJ
Advisory panel: Orthopedic
Date received: 1990-04-05
Decision date: 1990-08-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LWJ

product code LWJ

Injury: 544
Total: 544

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.