CORNERSTONE (R) PSR CERVICAL FUSION SYSTEM— 510(k) K111264

Name: FDA 510(k) clearance K111264
Creator: U.S. Food and Drug Administration
Published: 2011-10-12

Substantially Equivalent

Medtronic Sofamor Danek USA

FDA 510(k) clearance K111264 for CORNERSTONE (R) PSR CERVICAL FUSION SYSTEM, Substantially Equivalent on 2011-10-12. Applicant: Medtronic Sofamor Danek USA. Device class: 2.

Clearance details

Applicant: Medtronic Sofamor Danek USA
Product code: Code ODP
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2011-05-04
Decision date: 2011-10-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Memphis, TN, US

Download summary PDF View on FDA.gov ↗

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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.