ANATOMIC PEEK CERVICAL FUSION SYSTEM CORNERSTONE PSR CERVICAL FUSION SYSTEM PEEK PREVAIL CERVICAL INTERBODY DEVICE CAPST— 510(k) K122037

Substantially Equivalent

Medtronic Sofamor Danek, Inc.

FDA 510(k) clearance K122037 for ANATOMIC PEEK CERVICAL FUSION SYSTEM CORNERSTONE PSR CERVICAL FUSION SYSTEM PEEK PREVAIL CERVICAL INTERBODY DEVICE CAPST, Substantially Equivalent on 2013-03-22. Applicant: Medtronic Sofamor Danek, Inc..

Clearance details

Applicant: Medtronic Sofamor Danek, Inc.
Product code: Code MAX
Advisory panel: Orthopedic
Date received: 2012-07-11
Decision date: 2013-03-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, US

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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.