TRANS1 INTERBODY FUSION SYSTEM— 510(k) K120991

Substantially Equivalent

Trans1 Incorporated

FDA 510(k) clearance K120991 for TRANS1 INTERBODY FUSION SYSTEM, Substantially Equivalent on 2012-08-23. Applicant: Trans1 Incorporated.

Clearance details

Applicant: Trans1 Incorporated
Product code: Code MAX
Advisory panel: Orthopedic
Date received: 2012-04-02
Decision date: 2012-08-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wilmington, NC, 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.