FDA 510(k)

Sorrento Bioglass Bone Graft Substitute

K-번호: K173933 · 2018-09-13

결정일2018-09-13

제품 코드MQV

자문 위원회OR

결정Substantially Equivalent

기기 요약

Sorrento Bioglass Bone Graft Substitute is the device name listed in this FDA 510(k) record. The listed applicant is Xenco Medical, LLC. It received FDA 510(k) clearance on 2018-09-13 under 510(k) number K173933. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Sorrento Bioglass Bone Graft Substitute?

Sorrento Bioglass Bone Graft Substitute is a medical device that received FDA 510(k) clearance on 2018-09-13. The listed applicant is Xenco Medical, LLC. The 510(k) number is K173933.

When did Sorrento Bioglass Bone Graft Substitute receive FDA 510(k) clearance?

Sorrento Bioglass Bone Graft Substitute received FDA 510(k) clearance on 2018-09-13, under 510(k) number K173933.

Who is the listed applicant for Sorrento Bioglass Bone Graft Substitute?

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

What is the FDA product code for Sorrento Bioglass Bone Graft Substitute?

The FDA product code for Sorrento Bioglass Bone Graft Substitute is MQV.

Xenco Medical, LLC를 신청인으로 등재한 기타 기록

K243673Xenco Medical CancelleX Cervical Interbody System K223059Xenco Medical InterAlign Cervical Interbody System K213456Xenco Medical Multilevel CerviKit K191074Sorrento Bone Graft Substitute K190364CancelleX Porous Titanium Lumbar Interbody Device K180373CancelleX Porous Titanium Lumbar Interbody Device

11개 장치 모두 보기 →

관련 기기 (코드: MQV)

공식 출처

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