Intramedullary Nail System

FDA 510(k) K122994 · Weigao Orthopaedic Device Co., Ltd.

Substantially Equivalent

510(k) numberK122994

Submission

Device name
Intramedullary Nail System
Applicant
Weigao Orthopaedic Device Co., Ltd.
Shanghai, CN
Received
September 27, 2012
Decision date
April 12, 2013
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MNH – Orthosis, Spondylolisthesis Spinal Fixation
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3070
Specialty
Orthopedic
Implant
Yes

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Questions and answers

When was Intramedullary Nail System cleared by the FDA?

Intramedullary Nail System (K122994) received a 510(k) decision of Substantially Equivalent on April 12, 2013, 197 days after the submission was received.

What is the product code of K122994?

The FDA product code is MNH – Orthosis, Spondylolisthesis Spinal Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3070.