FDA 510(k)

ELEOS 다리 구조 보존 시스템, BIOGRIP을 특징으로 합니다.

K-번호: K203090 · 2020-12-11

결정일2020-12-11

제품 코드JDI

자문 위원회OR

결정Substantially Equivalent

기기 요약

ELEOS Limb Salvage System featuring BIOGRIP is the device name listed in this FDA 510(k) record. The listed applicant is Onkos Surgical. It received FDA 510(k) clearance on 2020-12-11 under 510(k) number K203090. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the ELEOS Limb Salvage System featuring BIOGRIP?

ELEOS Limb Salvage System featuring BIOGRIP is a medical device that received FDA 510(k) clearance on 2020-12-11. The listed applicant is Onkos Surgical. The 510(k) number is K203090.

When did ELEOS Limb Salvage System featuring BIOGRIP receive FDA 510(k) clearance?

ELEOS Limb Salvage System featuring BIOGRIP received FDA 510(k) clearance on 2020-12-11, under 510(k) number K203090.

Who is the listed applicant for ELEOS Limb Salvage System featuring BIOGRIP?

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

What is the FDA product code for ELEOS Limb Salvage System featuring BIOGRIP?

The FDA product code for ELEOS Limb Salvage System featuring BIOGRIP is JDI.

Onkos Surgical를 신청인으로 등재한 기타 기록

K212815My3D® 개인 맞춤형 골반 재건술 K211677ELEOS 근육 보존 시스템 K203815ELEOS 다리 구조 보존 시스템과 BioGrip K203588ELEOS™ 다리 구조 보존 시스템

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