MYSPINE PEDICLE SCREW PLACEMENT GUIDES— 510(k) K132788

Substantially Equivalent

Medacta International

FDA 510(k) clearance K132788 for MYSPINE PEDICLE SCREW PLACEMENT GUIDES, Substantially Equivalent on 2014-05-23. Applicant: Medacta International.

Clearance details

Applicant: Medacta International
Product code: Code MNI
Advisory panel: Orthopedic
Date received: 2013-09-06
Decision date: 2014-05-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Camarillo, CA, US

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Adverse events under product code MNI

product code MNI

Injury: 641
Total: 641

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.