Thor Anterior Plating System

FDA 510(k) K073437 · Stryker Spine

Substantially Equivalent

510(k) numberK073437

Submission

Device name
Thor Anterior Plating System
Applicant
Stryker Spine
Allendale, NJ, US
Received
December 6, 2007
Decision date
February 13, 2008
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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K254182AsterKWQ · Traditional Osteonic Co., Ltd.02/26/2026SE
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Questions and answers

When was Thor Anterior Plating System cleared by the FDA?

Thor Anterior Plating System (K073437) received a 510(k) decision of Substantially Equivalent on February 13, 2008, 69 days after the submission was received.

What is the product code of K073437?

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