FDA 510(k)

NeoSpan Compression Staple Impant w/instruments

K号: K161426 · 2016-10-24

决定日期2016-10-24

产品代码JDR

咨询委员会OR

决定Substantially Equivalent

器械摘要

NeoSpan Compression Staple Impant w/instruments is the device name listed in this FDA 510(k) record. The listed applicant is In2bones USA, LLC. It received FDA 510(k) clearance on 2016-10-24 under 510(k) number K161426. The device is classified under product code JDR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the NeoSpan Compression Staple Impant w/instruments?

NeoSpan Compression Staple Impant w/instruments is a medical device that received FDA 510(k) clearance on 2016-10-24. The listed applicant is In2bones USA, LLC. The 510(k) number is K161426.

When did NeoSpan Compression Staple Impant w/instruments receive FDA 510(k) clearance?

NeoSpan Compression Staple Impant w/instruments received FDA 510(k) clearance on 2016-10-24, under 510(k) number K161426.

Who is the listed applicant for NeoSpan Compression Staple Impant w/instruments?

The FDA 510(k) record lists In2bones USA, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NeoSpan Compression Staple Impant w/instruments?

The FDA product code for NeoSpan Compression Staple Impant w/instruments is JDR.

列明In2bones USA, LLC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。

K261154CoLink® & CoLag® Non-Sterile Screws K233089NeoSpan® Compression Implant System K231236IBS-B MIS Beveled Screw System K213698CoLink PCR Plating System K220260Hercules Syndesmosis Implant System K212872Avenger Radial Head System

查看所有 26 个设备 →

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。