KINAMED CERAMIC ATH TOTAL HIP - 28MM BALL— 510(k) K894904

Substantially Equivalent for Some Indications

Kinamed, Inc.

FDA 510(k) clearance K894904 for KINAMED CERAMIC ATH TOTAL HIP - 28MM BALL, Substantially Equivalent for Some Indications on 1990-03-19. Applicant: Kinamed, Inc..

Clearance details

Applicant: Kinamed, Inc.
Product code: Code LZO
Advisory panel: Orthopedic
Date received: 1989-08-01
Decision date: 1990-03-19
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LZO

product code LZO

Death: 17
Injury: 12,942
Malfunction: 1,756
Total: 14,715

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.