FDA 510(k)

Medline UNITE® Ankle Fusion Plating System

K-번호: K222665 · 2023-01-25

결정일2023-01-25

제품 코드HRS

자문 위원회OR

결정Substantially Equivalent

기기 요약

Medline UNITE® Ankle Fusion Plating System is the device name listed in this FDA 510(k) record. The listed applicant is Medline Industries, Inc.. It received FDA 510(k) clearance on 2023-01-25 under 510(k) number K222665. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Medline UNITE® Ankle Fusion Plating System?

Medline UNITE® Ankle Fusion Plating System is a medical device that received FDA 510(k) clearance on 2023-01-25. The listed applicant is Medline Industries, Inc.. The 510(k) number is K222665.

When did Medline UNITE® Ankle Fusion Plating System receive FDA 510(k) clearance?

Medline UNITE® Ankle Fusion Plating System received FDA 510(k) clearance on 2023-01-25, under 510(k) number K222665.

Who is the listed applicant for Medline UNITE® Ankle Fusion Plating System?

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

What is the FDA product code for Medline UNITE® Ankle Fusion Plating System?

The FDA product code for Medline UNITE® Ankle Fusion Plating System is HRS.

Medline Industries, Inc.를 신청인으로 등재한 기타 기록

K230559Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), Hudson RCI® Disposable Humidifier with 6 PSI Pressure Relief Valve (3260)K223100Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14)K213054Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe K212911Konig Mogen Clamp K220565Hudson RCI Triflo II Incentive Deep Breathing Exerciser K213481Medline General Surgery Tray

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