XYcor® Expandable Spinal Spacer System
K号: K160646 · 2016-08-24
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器械摘要
XYcor® Expandable Spinal Spacer System is the device name listed in this FDA 510(k) record. The listed applicant is Alphatec Spine, Inc.. It received FDA 510(k) clearance on 2016-08-24 under 510(k) number K160646. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the XYcor® Expandable Spinal Spacer System?
XYcor® Expandable Spinal Spacer System is a medical device that received FDA 510(k) clearance on 2016-08-24. The listed applicant is Alphatec Spine, Inc.. The 510(k) number is K160646.
When did XYcor® Expandable Spinal Spacer System receive FDA 510(k) clearance?
XYcor® Expandable Spinal Spacer System received FDA 510(k) clearance on 2016-08-24, under 510(k) number K160646.
Who is the listed applicant for XYcor® Expandable Spinal Spacer System?
The FDA 510(k) record lists Alphatec Spine, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for XYcor® Expandable Spinal Spacer System?
The FDA product code for XYcor® Expandable Spinal Spacer System is MAX.
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列明Alphatec Spine, 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。
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相关器械（代码：MAX）
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。
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官方来源
在 FDA 数据库中查看 →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。
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