CORNERSTONE PSR CERVICAL INTERBODY FUSION DEVICE— 510(k) K100214

Substantially Equivalent

Medtronic Sofamor Danek

FDA 510(k) clearance K100214 for CORNERSTONE PSR CERVICAL INTERBODY FUSION DEVICE, Substantially Equivalent on 2010-06-25. Applicant: Medtronic Sofamor Danek.

Clearance details

Applicant: Medtronic Sofamor Danek
Product code: Code ODP
Advisory panel: Orthopedic
Date received: 2010-01-25
Decision date: 2010-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, US

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Adverse events under product code ODP

product code ODP

Injury: 310
Total: 310

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.