SIMPLEX P SPEEDSET WITH TOBRAMYCIN BONE CEMENT— 510(k) K063857

Substantially Equivalent

Howmedica Osteonics Corp.

FDA 510(k) clearance K063857 for SIMPLEX P SPEEDSET WITH TOBRAMYCIN BONE CEMENT, Substantially Equivalent on 2007-02-26. Applicant: Howmedica Osteonics Corp..

Clearance details

Applicant: Howmedica Osteonics Corp.
Product code: Code MBB
Advisory panel: Orthopedic
Date received: 2006-12-28
Decision date: 2007-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mahwah, NJ, US

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Adverse events under product code MBB

product code MBB

Death: 27
Injury: 1,412
Malfunction: 551
Total: 1,990

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.