FDA 510(k)

可吸收螺钉的Taps

K号: K153587 · 2017-01-18

决定日期2017-01-18

产品代码HBG

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决定实质等同

器械摘要

Taps for Resorbable Screws is the device name listed in this FDA 510(k) record. The listed applicant is Synthes (USA) Products, LLC. It received FDA 510(k) clearance on 2017-01-18 under 510(k) number K153587. The device is classified under product code HBG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Taps for Resorbable Screws?

Taps for Resorbable Screws is a medical device that received FDA 510(k) clearance on 2017-01-18. The listed applicant is Synthes (USA) Products, LLC. The 510(k) number is K153587.

When did Taps for Resorbable Screws receive FDA 510(k) clearance?

Taps for Resorbable Screws received FDA 510(k) clearance on 2017-01-18, under 510(k) number K153587.

Who is the listed applicant for Taps for Resorbable Screws?

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

What is the FDA product code for Taps for Resorbable Screws?

The FDA product code for Taps for Resorbable Screws is HBG.

列明Synthes (USA) Products, 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。

K254087MAXFRAME AUTOSTRUT™ 带蓝牙多轴向校正系统 K212943SyntheCel Dura Repair K211313MAXFRAME 多轴向校正系统（又称 MAXFRAME）K210408DePuy Synthes 可变角度锁定髌骨钢板系统 K210205DePuy Synthes 3.5/4.5 mm 可变角度 LCP 假体近端股骨板系统 K201346DePuy Synthes 逆行股骨钉高级系统，DePuy Synthes 骨髓钉锁定螺钉，5.0 毫米

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