FDA 510(k)

MONTAGE可调，可吸收止血骨粘合剂

K号: K213418 · 2023-08-30

决定日期2023-08-30

产品代码MTJ

决定实质等同

器械摘要

MONTAGE Settable, Resorbable Hemostatic 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 2023-08-30 under 510(k) number K213418. The device is classified under product code MTJ. FDA Decision: Substantially Equivalent.

常见问题

What is the MONTAGE Settable, Resorbable Hemostatic Bone Putty?

MONTAGE Settable, Resorbable Hemostatic Bone Putty is a medical device that received FDA 510(k) clearance on 2023-08-30. The listed applicant is Orthocon, Inc.. The 510(k) number is K213418.

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

MONTAGE Settable, Resorbable Hemostatic Bone Putty received FDA 510(k) clearance on 2023-08-30, under 510(k) number K213418.

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

FDA 510(k)记录中列出Orthocon, Inc.为申请人。这本身并不能确立该设备制造商的身份。

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

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

列明Orthocon, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K262769Permatage XT 可调非吸收性止血骨泥（OS-PER-1001XT）K261265Permatage XT可调骨粘合剂 K261439Permatage 流动性、可设定止血骨粘合剂 K253447Montage 可流动设定，可吸收骨水泥（骨孔盖）K253732Permatage 流动性、可设定骨粘合剂 K253854MONTAGE XT颅骨水泥

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官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。