OsteoFab Patient Specific Cranial Device
K-Number: K180064 · 2018-07-27
Device Summary
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. The listed applicant is Oxford Performance Materials, Inc.. The 510(k) number is K180064.
When did OsteoFab Patient Specific Cranial Device receive FDA 510(k) clearance?
OsteoFab Patient Specific Cranial Device received FDA 510(k) clearance on 2018-07-27, under 510(k) number K180064.
Who is the listed applicant for OsteoFab Patient Specific Cranial Device?
The FDA 510(k) record lists Oxford Performance Materials, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for OsteoFab Patient Specific Cranial Device?
The FDA product code for OsteoFab Patient Specific Cranial Device is GXN.
Other records listing Oxford Performance Materials, Inc. as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: GXN)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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.