NEXGEN POROUS, HA/TCP, UNCEMENTED FEMORAL AND TIBIAL BASEPLATE COMPONENTS— 510(k) K041100

Substantially Equivalent

Zimmer, Inc.

FDA 510(k) clearance K041100 for NEXGEN POROUS, HA/TCP, UNCEMENTED FEMORAL AND TIBIAL BASEPLATE COMPONENTS, Substantially Equivalent on 2004-10-29. Applicant: Zimmer, Inc..

Clearance details

Applicant: Zimmer, Inc.
Product code: Code MBH
Advisory panel: Orthopedic
Date received: 2004-04-27
Decision date: 2004-10-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Warsaw, IN, US

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Adverse events under product code MBH

product code MBH

Injury: 6,545
Malfunction: 2,023
Total: 8,568

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.