CapLOX II/TowerLOX Pedicle Screw System— 510(k) K151116

Substantially Equivalent

Captiva Spine

FDA 510(k) clearance K151116 for CapLOX II/TowerLOX Pedicle Screw System, Substantially Equivalent on 2015-06-26. Applicant: Captiva Spine.

Clearance details

Applicant: Captiva Spine
Product code: Code MNH
Advisory panel: Orthopedic
Date received: 2015-04-27
Decision date: 2015-06-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Jupiter, FL, 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.