FDA 510(k)

XLO Brand of Locking Distal Humerus Plating System

K-번호: K233873 · 2024-04-26

결정일2024-04-26

제품 코드HRS

자문 위원회OR

결정Substantially Equivalent

기기 요약

XLO Brand of Locking Distal Humerus Plating System is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Life Systems Private Limited. It received FDA 510(k) clearance on 2024-04-26 under 510(k) number K233873. 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 XLO Brand of Locking Distal Humerus Plating System?

XLO Brand of Locking Distal Humerus Plating System is a medical device that received FDA 510(k) clearance on 2024-04-26. The listed applicant is Ortho Life Systems Private Limited. The 510(k) number is K233873.

When did XLO Brand of Locking Distal Humerus Plating System receive FDA 510(k) clearance?

XLO Brand of Locking Distal Humerus Plating System received FDA 510(k) clearance on 2024-04-26, under 510(k) number K233873.

Who is the listed applicant for XLO Brand of Locking Distal Humerus Plating System?

The FDA 510(k) record lists Ortho Life Systems Private Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for XLO Brand of Locking Distal Humerus Plating System?

The FDA product code for XLO Brand of Locking Distal Humerus Plating System is HRS.

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XLO Brand of Locking Distal Humerus Plating System

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: HRS)

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