FDA 510(k)

Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw

K-번호: K231819 · 2023-09-05

결정일2023-09-05

제품 코드HWC

자문 위원회OR

결정Substantially Equivalent

기기 요약

Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw is the device name listed in this FDA 510(k) record. The listed applicant is Innovate Orthopaedics Limited. It received FDA 510(k) clearance on 2023-09-05 under 510(k) number K231819. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw?

Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw is a medical device that received FDA 510(k) clearance on 2023-09-05. The listed applicant is Innovate Orthopaedics Limited. The 510(k) number is K231819.

When did Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw receive FDA 510(k) clearance?

Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw received FDA 510(k) clearance on 2023-09-05, under 510(k) number K231819.

Who is the listed applicant for Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw?

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

What is the FDA product code for Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw?

The FDA product code for Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw is HWC. This falls under the Cardiovascular category.

Innovate Orthopaedics Limited를 신청인으로 등재한 기타 기록

K212547Quick-Start Screws

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