INERTIA PEDICLE SCREW SYSTEM, HONOUR SPACER SYSTEM, FACET FIXX, STRUXXURE ANTERIOR CERVICAL PLATE AND SCREWS— 510(k) K141376

Substantially Equivalent

Nexxt Spine, LLC

FDA 510(k) clearance K141376 for INERTIA PEDICLE SCREW SYSTEM, HONOUR SPACER SYSTEM, FACET FIXX, STRUXXURE ANTERIOR CERVICAL PLATE AND SCREWS, Substantially Equivalent on 2014-06-26. Applicant: Nexxt Spine, LLC.

Clearance details

Applicant: Nexxt Spine, LLC
Product code: Code MNH
Advisory panel: Orthopedic
Date received: 2014-05-27
Decision date: 2014-06-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Chesterland, 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.