ALEUTIAN SPACER, MODEL K2-07-1004-01, K2-07-1005-01— 510(k) K080024

Substantially Equivalent

K2m, Inc.

FDA 510(k) clearance K080024 for ALEUTIAN SPACER, MODEL K2-07-1004-01, K2-07-1005-01, Substantially Equivalent on 2008-01-24. Applicant: K2m, Inc..

Clearance details

Applicant: K2m, Inc.
Product code: Code MQP
Advisory panel: Orthopedic
Date received: 2008-01-04
Decision date: 2008-01-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Leesburg, VA, US

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Adverse events under product code MQP

product code MQP

Injury: 372
Malfunction: 519
Total: 891

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.