ASFORA ANTERIOR CERVICAL PLATE SYSTEM, ONE LEVEL, 14MM ASFORA ANTERIOR CERVICAL PLATE SYSTEM, ONE LEVEL, 16MM— 510(k) K122497

Substantially Equivalent

Medical Design, LLC

FDA 510(k) clearance K122497 for ASFORA ANTERIOR CERVICAL PLATE SYSTEM, ONE LEVEL, 14MM ASFORA ANTERIOR CERVICAL PLATE SYSTEM, ONE LEVEL, 16MM, Substantially Equivalent on 2012-10-15. Applicant: Medical Design, LLC.

Clearance details

Applicant: Medical Design, LLC
Product code: Code KWQ
Advisory panel: Orthopedic
Date received: 2012-08-16
Decision date: 2012-10-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sioux Falls, SD, US

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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.