ADVANCE HA COATED SPIKED TIBIAL BASE AND ADVANCE HA COATED MODULAR KEEL— 510(k) K043083

Name: FDA 510(k) clearance K043083
Creator: U.S. Food and Drug Administration
Published: 2005-04-18

Substantially Equivalent

Wrightmedicaltechnologyinc

FDA 510(k) clearance K043083 for ADVANCE HA COATED SPIKED TIBIAL BASE AND ADVANCE HA COATED MODULAR KEEL, Substantially Equivalent on 2005-04-18. Applicant: Wrightmedicaltechnologyinc. Device class: 2.

Clearance details

Applicant: Wrightmedicaltechnologyinc
Product code: Code MBH
Device class: Class 2
Regulation: 21 CFR 888.3565
Advisory panel: Orthopedic
Date received: 2004-11-08
Decision date: 2005-04-18
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Arlington, TN, US

Download summary PDF View on FDA.gov ↗

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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.