XTEND-ST NUCLEUS REMOVAL SYSTEM, MODEL 9004— 510(k) K090303

Substantially Equivalent

Corespine Technologies, LLC

FDA 510(k) clearance K090303 for XTEND-ST NUCLEUS REMOVAL SYSTEM, MODEL 9004, Substantially Equivalent on 2009-04-30. Applicant: Corespine Technologies, LLC.

Clearance details

Applicant: Corespine Technologies, LLC
Product code: Code HRX
Advisory panel: Orthopedic
Date received: 2009-02-06
Decision date: 2009-04-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, 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.