ASFORA ANTERIOR CERVICAL PLATE SYSTEM— 510(k) K143688

Name: FDA 510(k) clearance K143688
Creator: U.S. Food and Drug Administration
Published: 2015-07-01

Substantially Equivalent

Medical Designs, LLC

FDA 510(k) clearance K143688 for ASFORA ANTERIOR CERVICAL PLATE SYSTEM, Substantially Equivalent on 2015-07-01. Applicant: Medical Designs, LLC. Device class: 2.

Clearance details

Applicant: Medical Designs, LLC
Product code: Code KWQ
Device class: Class 2
Regulation: 21 CFR 888.3060
Advisory panel: Orthopedic
Date received: 2014-12-24
Decision date: 2015-07-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sioux Falls, SD, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KWQ

product code KWQ

Death: 8
Injury: 1,212
Malfunction: 1,233
Total: 2,453

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.