KIRSCHNER SELF-TAPPING ACETABULAR CUP— 510(k) K852351

Substantially Equivalent

Kirschner Medical Corp.

FDA 510(k) clearance K852351 for KIRSCHNER SELF-TAPPING ACETABULAR CUP, Substantially Equivalent on 1985-08-09. Applicant: Kirschner Medical Corp..

Clearance details

Applicant: Kirschner Medical Corp.
Product code: Code KWA
Advisory panel: Orthopedic
Date received: 1985-05-31
Decision date: 1985-08-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Timonium, MD, US

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Adverse events under product code KWA

product code KWA

Death: 38
Injury: 10,439
Malfunction: 1,862
Total: 12,339

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.