Mixed Media Marker

FDA 510(k) K102506 · Cortex Manufacturing, Inc.

Substantially Equivalent

510(k) numberK102506

Submission

Device name
Mixed Media Marker
Applicant
Cortex Manufacturing, Inc.
Lake Stevens, WA, US
Received
September 1, 2010
Decision date
January 12, 2011
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NEU – Marker, Radiographic, Implantable
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4300
Specialty
General, Plastic Surgery
Implant
Yes

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Questions and answers

When was Mixed Media Marker cleared by the FDA?

Mixed Media Marker (K102506) received a 510(k) decision of Substantially Equivalent on January 12, 2011, 133 days after the submission was received.

What is the product code of K102506?

The FDA product code is NEU – Marker, Radiographic, Implantable, a Class II (moderate risk) device regulated under 21 CFR 878.4300.