CORE PEDICLE SCREW SYSTEM— 510(k) K131522

Substantially Equivalent

Core-Nexus

FDA 510(k) clearance K131522 for CORE PEDICLE SCREW SYSTEM, Substantially Equivalent on 2013-08-09. Applicant: Core-Nexus.

Clearance details

Applicant: Core-Nexus
Product code: Code MNI
Advisory panel: Orthopedic
Date received: 2013-05-28
Decision date: 2013-08-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

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.