510(k) K905334— THOMPSON TYPE HIP PROSTHESIS

Substantially Equivalent

O'Tec Corp.

Clearance details

Applicant: O'Tec Corp.
Product code: Code KWL
Advisory panel: Orthopedic
Date received: 1990-11-28
Decision date: 1990-12-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, US

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.