Synthes Matrixmadible Plate and Screw System
FDA 510(k) K113567 · Synthes, Inc.
510(k) numberK113567
Submission
- Device name
- Synthes Matrixmadible Plate and Screw System
- Applicant
- Synthes, Inc.
West Chester, PA, US - Received
- December 2, 2011
- Decision date
- November 19, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Synthes Matrixmadible Plate and Screw System cleared by the FDA?
Synthes Matrixmadible Plate and Screw System (K113567) received a 510(k) decision of Substantially Equivalent on November 19, 2012, 353 days after the submission was received.
What is the product code of K113567?
The FDA product code is JEY – Plate, Bone, a Class II (moderate risk) device regulated under 21 CFR 872.4760.