TiWAVE-C Porous Titanium Cervical Cage— 510(k) K180401

Substantially Equivalent

Kalitec Direct, LLC

FDA 510(k) clearance K180401 for TiWAVE-C Porous Titanium Cervical Cage, Substantially Equivalent on 2018-06-14. Applicant: Kalitec Direct, LLC.

Clearance details

Applicant: Kalitec Direct, LLC
Product code: Code ODP
Advisory panel: Orthopedic
Date received: 2018-02-14
Decision date: 2018-06-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orlando, FL, 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.