Stryker Universal Orbital Floor System
FDA 510(k) K123786 · Stryker
510(k) numberK123786
Submission
- Device name
- Stryker Universal Orbital Floor System
- Applicant
- Stryker
Portage, MI, US - Received
- December 10, 2012
- Decision date
- April 9, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Stryker Universal Orbital Floor System cleared by the FDA?
Stryker Universal Orbital Floor System (K123786) received a 510(k) decision of Substantially Equivalent on April 9, 2013, 120 days after the submission was received.
What is the product code of K123786?
The FDA product code is JEY – Plate, Bone, a Class II (moderate risk) device regulated under 21 CFR 872.4760.