MAC MALE ADAPTER— 510(k) K102843

Name: FDA 510(k) clearance K102843
Creator: U.S. Food and Drug Administration
Published: 2011-05-03

Substantially Equivalent

Biomet Trauma (Aka Ebi, LLC)

FDA 510(k) clearance K102843 for MAC MALE ADAPTER, Substantially Equivalent on 2011-05-03. Applicant: Biomet Trauma (Aka Ebi, LLC). Device class: 2.

Clearance details

Applicant: Biomet Trauma (Aka Ebi, LLC)
Product code: Code KTT
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2010-09-29
Decision date: 2011-05-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Parsippany, NJ, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KTT

product code KTT

Death: 11
Injury: 3,097
Malfunction: 1,261
Total: 4,369

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.