FDA 510(k)

TRELLIS™ SI Joint Fusion System

K-번호: K212962 · 2022-04-11

결정일2022-04-11

제품 코드OUR

자문 위원회OR

결정Substantially Equivalent

기기 요약

TRELLIS™ SI Joint Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Orthofundamentals, LLC. It received FDA 510(k) clearance on 2022-04-11 under 510(k) number K212962. The device is classified under product code OUR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the TRELLIS™ SI Joint Fusion System?

TRELLIS™ SI Joint Fusion System is a medical device that received FDA 510(k) clearance on 2022-04-11. The listed applicant is Orthofundamentals, LLC. The 510(k) number is K212962.

When did TRELLIS™ SI Joint Fusion System receive FDA 510(k) clearance?

TRELLIS™ SI Joint Fusion System received FDA 510(k) clearance on 2022-04-11, under 510(k) number K212962.

Who is the listed applicant for TRELLIS™ SI Joint Fusion System?

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

What is the FDA product code for TRELLIS™ SI Joint Fusion System?

The FDA product code for TRELLIS™ SI Joint Fusion System is OUR.

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TRELLIS™ SI Joint Fusion System

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: OUR)

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