TranS1 Interbody Fusion System— 510(k) K191791

Name: FDA 510(k) clearance K191791
Creator: U.S. Food and Drug Administration
Published: 2019-09-25

Substantially Equivalent

Trans1

FDA 510(k) clearance K191791 for TranS1 Interbody Fusion System, Substantially Equivalent on 2019-09-25. Applicant: Trans1. Device class: 2.

Clearance details

Applicant: Trans1
Product code: Code MAX
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2019-07-03
Decision date: 2019-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wilmington, NC, US

Download summary PDF View on FDA.gov ↗

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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.