FDA 510(k)

MONTAGE 설정 가능, 흡수 가능한 뼈 푸티

K-번호: K221933 · 2023-01-13

결정일2023-01-13

제품 코드GXP

자문 위원회NE (이 문서는 원문이 제공되지 않았기 때문에 번역할 수 없습니다. 원문을 제공해 주시면 번역을 도와드리겠습니다.)

결정Substantially Equivalent

기기 요약

MONTAGE Settable, Resorbable Bone Putty is the device name listed in this FDA 510(k) record. The listed applicant is Orthocon, Inc.. It received FDA 510(k) clearance on 2023-01-13 under 510(k) number K221933. The device is classified under product code GXP. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the MONTAGE Settable, Resorbable Bone Putty?

MONTAGE Settable, Resorbable Bone Putty is a medical device that received FDA 510(k) clearance on 2023-01-13. The listed applicant is Orthocon, Inc.. The 510(k) number is K221933.

When did MONTAGE Settable, Resorbable Bone Putty receive FDA 510(k) clearance?

MONTAGE Settable, Resorbable Bone Putty received FDA 510(k) clearance on 2023-01-13, under 510(k) number K221933.

Who is the listed applicant for MONTAGE Settable, Resorbable Bone Putty?

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

What is the FDA product code for MONTAGE Settable, Resorbable Bone Putty?

The FDA product code for MONTAGE Settable, Resorbable Bone Putty is GXP.

Orthocon, Inc.를 신청인으로 등재한 기타 기록

K262769Permatage XT Settable Nonabsorbable Hemostatic Bone Putty (OS-PER-1001XT)K261265Permatage XT Settable Bone Putty K261439Permatage Flowable, Settable Hemostatic Bone Paste K253447몽타주 플로우어블 세팅블, 재흡수 가능한 뼈 패스테(부르홀 커버)K253732Permatage Flowable, Settable Bone Paste K253854MONTAGE XT Cranial Cement

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