CORNICE Cervical Spacer System— 510(k) K192208

Name: FDA 510(k) clearance K192208
Creator: U.S. Food and Drug Administration
Published: 2019-10-09

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. Device class: 2.

Clearance details

Applicant: Legend Spine Technologies
Product code: Code ODP
Device class: Class 2
Regulation: 21 CFR 888.3080
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 ↗

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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.