Embrace Thermoplastic

FDA 510(k) K120335 · Bionix Development Corp.

Substantially Equivalent

510(k) numberK120335

Submission

Device name
Embrace Thermoplastic
Applicant
Bionix Development Corp.
Toledo, OH, US
Received
February 3, 2012
Decision date
May 3, 2012
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
IYE – Accelerator, Linear, Medical
Device class
Class II (moderate risk)
Regulation
21 CFR 892.5050
Specialty
Radiology

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Questions and answers

When was Embrace Thermoplastic cleared by the FDA?

Embrace Thermoplastic (K120335) received a 510(k) decision of Substantially Equivalent on May 3, 2012, 90 days after the submission was received.

What is the product code of K120335?

The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.