INTESS CERVICAL CAGE SYSTEM— 510(k) K133815

Name: FDA 510(k) clearance K133815
Creator: U.S. Food and Drug Administration
Published: 2014-04-16

Substantially Equivalent

Kalitec Direct, LLC

FDA 510(k) clearance K133815 for INTESS CERVICAL CAGE SYSTEM, Substantially Equivalent on 2014-04-16. Applicant: Kalitec Direct, LLC. Device class: 2.

Clearance details

Applicant: Kalitec Direct, LLC
Product code: Code ODP
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2013-12-16
Decision date: 2014-04-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Round Rock, TX, 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.