ORTHOGENESIS LPS PROXIMAL TIBIAL REPLACEMENT AND ORTHOGENESIS LPS TIBIAL BEARING— 510(k) K011810

Substantially Equivalent

Depuy, Inc.

FDA 510(k) clearance K011810 for ORTHOGENESIS LPS PROXIMAL TIBIAL REPLACEMENT AND ORTHOGENESIS LPS TIBIAL BEARING, Substantially Equivalent on 2001-09-07. Applicant: Depuy, Inc..

Clearance details

Applicant: Depuy, Inc.
Product code: Code KRO
Advisory panel: Orthopedic
Date received: 2001-06-11
Decision date: 2001-09-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, 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.