OsteoFab Patient Specific Cranial Device— 510(k) K180064

Name: FDA 510(k) clearance K180064
Creator: U.S. Food and Drug Administration
Published: 2018-07-27

Substantially Equivalent

Oxford Performance Materials, Inc.

FDA 510(k) clearance K180064 for OsteoFab Patient Specific Cranial Device, Substantially Equivalent on 2018-07-27. Applicant: Oxford Performance Materials, Inc.. Device class: 2.

Clearance details

Applicant: Oxford Performance Materials, Inc.
Product code: Code GXN
Device class: Class 2
Regulation: 21 CFR 882.5330
Advisory panel: Neurology
Date received: 2018-01-09
Decision date: 2018-07-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Windsor, CT, 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.