Metallic Intramedullary Nail System

FDA 510(k) K132078 · Tianjin Walkman Biomaterial Co., Ltd.

Substantially Equivalent

510(k) numberK132078

Submission

Device name
Metallic Intramedullary Nail System
Applicant
Tianjin Walkman Biomaterial Co., Ltd.
Shanghai, CN
Received
July 5, 2013
Decision date
March 19, 2014
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HSB – Rod, Fixation, Intramedullary And Accessories
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3020
Specialty
Orthopedic
Implant
Yes

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More from Fusion Orthopedics USA, LLC

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K140229General Spinal SystemMNI · Traditional 04/29/2014SE
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Questions and answers

When was Metallic Intramedullary Nail System cleared by the FDA?

Metallic Intramedullary Nail System (K132078) received a 510(k) decision of Substantially Equivalent on March 19, 2014, 257 days after the submission was received.

What is the product code of K132078?

The FDA product code is HSB – Rod, Fixation, Intramedullary And Accessories, a Class II (moderate risk) device regulated under 21 CFR 888.3020.