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FDA 510(k)

AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)

Número K: K253080 · 2026-06-18

RequerenteSuzhou and Science & Technology Development Corp.
Data da decisão2026-06-18
Código do produtoHSB
Comité consultivoOR
DecisãoSubstantially Equivalent

Resumo do dispositivo

AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02) is the device name listed in this FDA 510(k) record. The listed applicant is Suzhou and Science & Technology Development Corp.. It received FDA 510(k) clearance on 2026-06-18 under 510(k) number K253080. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)?

AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02) is a medical device that received FDA 510(k) clearance on 2026-06-18. The listed applicant is Suzhou and Science & Technology Development Corp.. The 510(k) number is K253080.

When did AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02) receive FDA 510(k) clearance?

AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02) received FDA 510(k) clearance on 2026-06-18, under 510(k) number K253080.

Who is the listed applicant for AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)?

The FDA 510(k) record lists Suzhou and Science & Technology Development Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)?

The FDA product code for AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02) is HSB.

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