FDA 510(k)

OsteoFab Patient Specific Cranial Device

K-번호: K180064 · 2018-07-27

결정일2018-07-27

제품 코드GXN

자문 위원회NE

결정Substantially Equivalent

기기 요약

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

자주 묻는 질문

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.

Oxford Performance Materials, Inc.를 신청인으로 등재한 기타 기록

K190915OsteoFab Suture Anchors K161052OsteoFab Patient Specific Facial Device

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