TRANS1 LATERAL INTERVERTEBRAL FUSION DEVICE, T— 510(k) K100210

Substantially Equivalent

Trans1 Incorporated

FDA 510(k) clearance K100210 for TRANS1 LATERAL INTERVERTEBRAL FUSION DEVICE, T, Substantially Equivalent on 2010-08-26. Applicant: Trans1 Incorporated.

Clearance details

Applicant: Trans1 Incorporated
Product code: Code MAX
Advisory panel: Orthopedic
Date received: 2010-01-25
Decision date: 2010-08-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wilmington, NC, US

Download summary PDF View on FDA.gov ↗

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.