FORTEX PEDICLE SCREW SYSTEM— 510(k) K120832

Substantially Equivalent

X-Spine Systems, Inc.

FDA 510(k) clearance K120832 for FORTEX PEDICLE SCREW SYSTEM, Substantially Equivalent on 2012-10-23. Applicant: X-Spine Systems, Inc..

Clearance details

Applicant: X-Spine Systems, Inc.
Product code: Code MNH
Advisory panel: Orthopedic
Date received: 2012-03-19
Decision date: 2012-10-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Miamisburg, OH, 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.