AXIALIF 2L, AXIALIF 2-LEVEL SYSTEM, AXIALIF APOLLO, AXIALIF II— 510(k) K092124

Substantially Equivalent

Trans1 Incorporated

FDA 510(k) clearance K092124 for AXIALIF 2L, AXIALIF 2-LEVEL SYSTEM, AXIALIF APOLLO, AXIALIF II, Substantially Equivalent on 2010-01-21. Applicant: Trans1 Incorporated.

Clearance details

Applicant: Trans1 Incorporated
Product code: Code KWQ
Advisory panel: Orthopedic
Date received: 2009-07-15
Decision date: 2010-01-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wilmington, NC, US

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Adverse events under product code KWQ

product code KWQ

Death: 8
Injury: 1,212
Malfunction: 1,233
Total: 2,453

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.