MEDCAD ACCUSHAPE (TM) PEEK PATIENT SPECIFIC CRANIAL / CRANIOFACIAL IMPLANT— 510(k) K110684

Name: FDA 510(k) clearance K110684
Creator: U.S. Food and Drug Administration
Published: 2011-06-24

Substantially Equivalent

Vanduzen Dba Medcad

FDA 510(k) clearance K110684 for MEDCAD ACCUSHAPE (TM) PEEK PATIENT SPECIFIC CRANIAL / CRANIOFACIAL IMPLANT, Substantially Equivalent on 2011-06-24. Applicant: Vanduzen Dba Medcad. Device class: 2.

Clearance details

Applicant: Vanduzen Dba Medcad
Product code: Code GXN
Device class: Class 2
Regulation: 21 CFR 882.5330
Advisory panel: Neurology
Date received: 2011-03-11
Decision date: 2011-06-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Richardson, TX, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GXN

product code GXN

Injury: 208
Total: 208

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.