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FDA 510(k)

OsteoFab Patient Specific Cranial Device

K-Number: K180064 · 2018-07-27

ApplicantOxford Performance Materials, Inc.
Decision Date2018-07-27
Product CodeGXN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

OsteoFab Patient Specific Cranial Device is a medical device manufactured by Oxford Performance Materials, Inc.. It received FDA 510(k) clearance on 2018-07-27 under approval number K180064. The device is classified under product code GXN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OsteoFab Patient Specific Cranial Device?

OsteoFab Patient Specific Cranial Device is a medical device that received FDA 510(k) clearance on 2018-07-27. It is manufactured by Oxford Performance Materials, Inc.. The 510(k) number is K180064.

When was OsteoFab Patient Specific Cranial Device approved by the FDA?

OsteoFab Patient Specific Cranial Device received FDA 510(k) clearance on 2018-07-27, under approval number K180064.

What company makes OsteoFab Patient Specific Cranial Device?

OsteoFab Patient Specific Cranial Device is manufactured by Oxford Performance Materials, Inc..

What is the FDA product code for OsteoFab Patient Specific Cranial Device?

The FDA product code for OsteoFab Patient Specific Cranial Device is GXN.

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Other Devices by Oxford Performance Materials, Inc.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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