NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL CONES PROVISIONALS TO NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL— 510(k) K120990

Substantially Equivalent

Zimmer Trabecular Metal Technology

FDA 510(k) clearance K120990 for NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL CONES PROVISIONALS TO NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL, Substantially Equivalent on 2012-06-29. Applicant: Zimmer Trabecular Metal Technology.

Clearance details

Applicant: Zimmer Trabecular Metal Technology
Product code: Code MBH
Advisory panel: Orthopedic
Date received: 2012-04-02
Decision date: 2012-06-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Parsippany, NJ, 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.