CORNICE Cervical Spacer System— 510(k) K192208

Substantially Equivalent

Legend Spine Technologies

FDA 510(k) clearance K192208 for CORNICE Cervical Spacer System, Substantially Equivalent on 2019-10-09. Applicant: Legend Spine Technologies.

Clearance details

Applicant: Legend Spine Technologies
Product code: Code ODP
Advisory panel: Orthopedic
Date received: 2019-08-14
Decision date: 2019-10-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bethlehem, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code ODP

product code ODP

Injury: 310
Total: 310

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.