TRANS1 TRANS-SACRAL SPINAL ACCESS AND PREPARATION KIT— 510(k) K032891

Substantially Equivalent

Trans1, Inc.

FDA 510(k) clearance K032891 for TRANS1 TRANS-SACRAL SPINAL ACCESS AND PREPARATION KIT, Substantially Equivalent on 2004-01-15. Applicant: Trans1, Inc..

Clearance details

Applicant: Trans1, Inc.
Product code: Code HRX
Advisory panel: Orthopedic
Date received: 2003-09-17
Decision date: 2004-01-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Excelsior, MN, US

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Adverse events under product code HRX

product code HRX

Injury: 623
Malfunction: 11,257
Total: 11,880

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.