BTM TOTAL HIP SYSTEM— 510(k) K852420

Substantially Equivalent

Kirschner Medical Corp.

FDA 510(k) clearance K852420 for BTM TOTAL HIP SYSTEM, Substantially Equivalent on 1985-06-28. Applicant: Kirschner Medical Corp..

Clearance details

Applicant: Kirschner Medical Corp.
Product code: Code KWL
Advisory panel: Orthopedic
Date received: 1985-06-07
Decision date: 1985-06-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Timonium, MD, US

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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.