FDA 510(k)

몽타주 플로우어블 세팅블, 흡수성 뼈 패스트

K-번호: K231270 · 2023-09-01

결정일2023-09-01

제품 코드MQV

자문 위원회OR

결정Substantially Equivalent

기기 요약

Montage Flowable Settable, Resorbable Bone Paste is the device name listed in this FDA 510(k) record. The listed applicant is Orthocon, Inc.. It received FDA 510(k) clearance on 2023-09-01 under 510(k) number K231270. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Montage Flowable Settable, Resorbable Bone Paste?

Montage Flowable Settable, Resorbable Bone Paste is a medical device that received FDA 510(k) clearance on 2023-09-01. The listed applicant is Orthocon, Inc.. The 510(k) number is K231270.

When did Montage Flowable Settable, Resorbable Bone Paste receive FDA 510(k) clearance?

Montage Flowable Settable, Resorbable Bone Paste received FDA 510(k) clearance on 2023-09-01, under 510(k) number K231270.

Who is the listed applicant for Montage Flowable Settable, Resorbable Bone Paste?

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 Flowable Settable, Resorbable Bone Paste?

The FDA product code for Montage Flowable Settable, Resorbable Bone Paste is MQV.

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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