Hedgehog Cervical Interbody Fusion Device— 510(k) K143685

Substantially Equivalent

Vertera, Inc.

FDA 510(k) clearance K143685 for Hedgehog Cervical Interbody Fusion Device, Substantially Equivalent on 2015-09-23. Applicant: Vertera, Inc..

Clearance details

Applicant: Vertera, Inc.
Product code: Code ODP
Advisory panel: Orthopedic
Date received: 2014-12-24
Decision date: 2015-09-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Atlanta, GA, 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.