FDA 510(k)

DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional

K-번호: K192702 · 2020-09-18

결정일2020-09-18

제품 코드GXN

자문 위원회NE

결정Substantially Equivalent

기기 요약

DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional is the device name listed in this FDA 510(k) record. The listed applicant is Synthes (USA) Products, LLC. It received FDA 510(k) clearance on 2020-09-18 under 510(k) number K192702. 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 DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional?

DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional is a medical device that received FDA 510(k) clearance on 2020-09-18. The listed applicant is Synthes (USA) Products, LLC. The 510(k) number is K192702.

When did DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional receive FDA 510(k) clearance?

DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional received FDA 510(k) clearance on 2020-09-18, under 510(k) number K192702.

Who is the listed applicant for DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional?

The FDA 510(k) record lists Synthes (USA) Products, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional?

The FDA product code for DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional is GXN.

Synthes (USA) Products, LLC를 신청인으로 등재한 기타 기록

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