MIDLINE II TI— 510(k) K141942

Substantially Equivalent

Centinel Spine, Inc.

FDA 510(k) clearance K141942 for MIDLINE II TI, Substantially Equivalent on 2014-11-07. Applicant: Centinel Spine, Inc..

Clearance details

Applicant: Centinel Spine, Inc.
Product code: Code OVD
Advisory panel: Orthopedic
Date received: 2014-07-17
Decision date: 2014-11-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OVD

product code OVD

Death: 5
Injury: 495
Total: 500

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.