KNEE SYSTEM, QUADRAXIAL CONSTRAINED— 510(k) K781971

Substantially Equivalent

Hexcel Medical

FDA 510(k) clearance K781971 for KNEE SYSTEM, QUADRAXIAL CONSTRAINED, Substantially Equivalent on 1979-04-04. Applicant: Hexcel Medical.

Clearance details

Applicant: Hexcel Medical
Product code: Code KRO
Advisory panel: Orthopedic
Date received: 1978-11-27
Decision date: 1979-04-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code KRO

product code KRO

Death: 19
Injury: 4,841
Total: 4,860

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.