FDA 510(k)

MONTAGE-QS可调，可吸收骨粘合剂

K号: K231475 · 2023-10-12

决定日期2023-10-12

产品代码GXP

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决定实质等同

器械摘要

MONTAGE-QS 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 2023-10-12 under 510(k) number K231475. The device is classified under product code GXP. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the MONTAGE-QS Settable, Resorbable Bone Putty?

MONTAGE-QS Settable, Resorbable Bone Putty is a medical device that received FDA 510(k) clearance on 2023-10-12. The listed applicant is Orthocon, Inc.. The 510(k) number is K231475.

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

MONTAGE-QS Settable, Resorbable Bone Putty received FDA 510(k) clearance on 2023-10-12, under 510(k) number K231475.

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

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

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。