Katia System

FDA 510(k) K131512 · Shanghai Sanyou Medical Co, Ltd.

Substantially Equivalent

510(k) numberK131512

Submission

Device name
Katia System
Applicant
Shanghai Sanyou Medical Co, Ltd.
Bartlett, TN, US
Received
May 28, 2013
Decision date
August 7, 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
KWQ – Appliance, Fixation, Spinal Intervertebral Body
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3060
Specialty
Orthopedic
Implant
Yes

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Questions and answers

When was Katia System cleared by the FDA?

Katia System (K131512) received a 510(k) decision of Substantially Equivalent on August 7, 2013, 71 days after the submission was received.

What is the product code of K131512?

The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.