FDA 510(k)

Airlock® Ankle Plating System

K-번호: K260274 · 2026-03-25

결정일2026-03-25

제품 코드HRS

자문 위원회OR

결정Substantially Equivalent

기기 요약

Airlock® Ankle Plating System is the device name listed in this FDA 510(k) record. The listed applicant is Novastep SAS. It received FDA 510(k) clearance on 2026-03-25 under 510(k) number K260274. 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 Airlock® Ankle Plating System?

Airlock® Ankle Plating System is a medical device that received FDA 510(k) clearance on 2026-03-25. The listed applicant is Novastep SAS. The 510(k) number is K260274.

When did Airlock® Ankle Plating System receive FDA 510(k) clearance?

Airlock® Ankle Plating System received FDA 510(k) clearance on 2026-03-25, under 510(k) number K260274.

Who is the listed applicant for Airlock® Ankle Plating System?

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

What is the FDA product code for Airlock® Ankle Plating System?

The FDA product code for Airlock® Ankle Plating System is HRS.

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Airlock® Ankle Plating System

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: HRS)

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