ALEUTIAN IBF SYSTEM— 510(k) K082698

Substantially Equivalent

K2m, Inc.

FDA 510(k) clearance K082698 for ALEUTIAN IBF SYSTEM, Substantially Equivalent on 2009-04-21. Applicant: K2m, Inc..

Clearance details

Applicant: K2m, Inc.
Product code: Code MAX
Advisory panel: Orthopedic
Date received: 2008-09-15
Decision date: 2009-04-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Leesburg, VA, US

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Adverse events under product code MAX

product code MAX

Death: 13
Injury: 1,305
Malfunction: 2,885
Total: 4,203

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.