FDA 510(k)

Permatage XT可调骨粘合剂

K号: K261265 · 2026-06-15

决定日期2026-06-15

产品代码GXP

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决定实质等同

器械摘要

Permatage XT Settable 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 2026-06-15 under 510(k) number K261265. 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 Permatage XT Settable Bone Putty?

Permatage XT Settable Bone Putty is a medical device that received FDA 510(k) clearance on 2026-06-15. The listed applicant is Orthocon, Inc.. The 510(k) number is K261265.

When did Permatage XT Settable Bone Putty receive FDA 510(k) clearance?

Permatage XT Settable Bone Putty received FDA 510(k) clearance on 2026-06-15, under 510(k) number K261265.

Who is the listed applicant for Permatage XT Settable 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 Permatage XT Settable Bone Putty?

The FDA product code for Permatage XT Settable 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）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 K243526MONTAGE可调，可吸收骨粘合剂 MONTAGE-QS可调，可吸收骨粘合剂 MONTAGE流动可调，可吸收骨糊 MONTAGE-XT可调，可吸收止血骨粘合剂

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官方来源

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