FDA 510(k)

7D Surgical System

K-번호: K192140 · 2019-11-05

결정일2019-11-05

제품 코드OLO

자문 위원회NE (이 문서는 원문이 제공되지 않았기 때문에 번역할 수 없습니다. 원문을 제공해 주시면 번역을 도와드리겠습니다.)

결정대체적으로 동일

기기 요약

7D Surgical System is the device name listed in this FDA 510(k) record. The listed applicant is 7D Surgical, Inc.. It received FDA 510(k) clearance on 2019-11-05 under 510(k) number K192140. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the 7D Surgical System?

7D Surgical System is a medical device that received FDA 510(k) clearance on 2019-11-05. The listed applicant is 7D Surgical, Inc.. The 510(k) number is K192140.

When did 7D Surgical System receive FDA 510(k) clearance?

7D Surgical System received FDA 510(k) clearance on 2019-11-05, under 510(k) number K192140.

Who is the listed applicant for 7D Surgical System?

The FDA 510(k) record lists 7D Surgical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 7D Surgical System?

The FDA product code for 7D Surgical System is OLO.

7D Surgical, Inc.를 신청인으로 등재한 기타 기록

K2104577D Registration Frame, 7D Flex Iliac Pin Connector, 7D Pin Guide Block, 7D 3.2 mm Steinmann Pin, 7D Iliac Crest Pin Chuck & Key K2105557D Surgical System - Drill Guide K2019667D Surgical FlashLock 1, 7D Surgical Flex Rod Connector - 5.5 mm - 150 mm, 7D Surgical Flex Array K1929457D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application K1832767D Surgical System K1810417D Surgical System Cranial Application

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