FDA 510(k)

HERA Interlocking Intramedullary Nailing System

K-번호: K253046 · 2026-06-16

신청자ZheJiang Decans Medical Devices Co., Ltd.

결정일2026-06-16

제품 코드HSB

자문 위원회OR

결정Substantially Equivalent

기기 요약

HERA Interlocking Intramedullary Nailing System is the device name listed in this FDA 510(k) record. The listed applicant is ZheJiang Decans Medical Devices Co., Ltd.. It received FDA 510(k) clearance on 2026-06-16 under 510(k) number K253046. 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 HERA Interlocking Intramedullary Nailing System?

HERA Interlocking Intramedullary Nailing System is a medical device that received FDA 510(k) clearance on 2026-06-16. The listed applicant is ZheJiang Decans Medical Devices Co., Ltd.. The 510(k) number is K253046.

When did HERA Interlocking Intramedullary Nailing System receive FDA 510(k) clearance?

HERA Interlocking Intramedullary Nailing System received FDA 510(k) clearance on 2026-06-16, under 510(k) number K253046.

Who is the listed applicant for HERA Interlocking Intramedullary Nailing System?

The FDA 510(k) record lists ZheJiang Decans Medical Devices Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HERA Interlocking Intramedullary Nailing System?

The FDA product code for HERA Interlocking Intramedullary Nailing System is HSB.

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