TRANS1 AXIALIF PLUS— 510(k) K102334

Substantially Equivalent

Trans1 Incorporated

FDA 510(k) clearance K102334 for TRANS1 AXIALIF PLUS, Substantially Equivalent on 2011-03-14. Applicant: Trans1 Incorporated.

Clearance details

Applicant: Trans1 Incorporated
Product code: Code KWQ
Advisory panel: Orthopedic
Date received: 2010-08-17
Decision date: 2011-03-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wilmington, NC, US

Download summary PDF View on FDA.gov ↗

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.