PedFuse Pedicle Screw System— 510(k) K143377

Substantially Equivalent

Spinefrontier, Inc.

FDA 510(k) clearance K143377 for PedFuse Pedicle Screw System, Substantially Equivalent on 2015-02-12. Applicant: Spinefrontier, Inc..

Clearance details

Applicant: Spinefrontier, Inc.
Product code: Code MNH
Advisory panel: Orthopedic
Date received: 2014-11-25
Decision date: 2015-02-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Beverly, MA, US

Download summary PDF View on FDA.gov ↗

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.