FDA 510(k)

T2 알파 페미어 레트로그레이드 나일링 시스템

K-번호: K250163 · 2025-08-13

결정일2025-08-13

제품 코드HSB

자문 위원회OR

결정Substantially Equivalent

기기 요약

T2 Alpha Femur Retrograde Nailing System is the device name listed in this FDA 510(k) record. The listed applicant is Stryker GmbH. It received FDA 510(k) clearance on 2025-08-13 under 510(k) number K250163. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the T2 Alpha Femur Retrograde Nailing System?

T2 Alpha Femur Retrograde Nailing System is a medical device that received FDA 510(k) clearance on 2025-08-13. The listed applicant is Stryker GmbH. The 510(k) number is K250163.

When did T2 Alpha Femur Retrograde Nailing System receive FDA 510(k) clearance?

T2 Alpha Femur Retrograde Nailing System received FDA 510(k) clearance on 2025-08-13, under 510(k) number K250163.

Who is the listed applicant for T2 Alpha Femur Retrograde Nailing System?

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

What is the FDA product code for T2 Alpha Femur Retrograde Nailing System?

The FDA product code for T2 Alpha Femur Retrograde Nailing System is HSB.

Stryker GmbH를 신청인으로 등재한 기타 기록

K261481Pangea Femur Reconstruction System K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System K253202Hoffmann LRF System K251400T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea Tibia Plating System K233919VariAx 2 Distal Radius System

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