THE MEHDIAN LUMBO-SACRAL PEDICLE SCREW SYSTEM— 510(k) K973425

Substantially Equivalent

Corin USA

FDA 510(k) clearance K973425 for THE MEHDIAN LUMBO-SACRAL PEDICLE SCREW SYSTEM, Substantially Equivalent on 1998-02-27. Applicant: Corin USA.

Clearance details

Applicant: Corin USA
Product code: Code MNH
Advisory panel: Orthopedic
Date received: 1997-09-10
Decision date: 1998-02-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tampa, FL, US

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Adverse events under product code MNH

product code MNH

Injury: 978
Malfunction: 793
Total: 1,771

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.