Synthes Patient Specific Plate
FDA 510(k) K122647 · Synthes, Inc.
510(k) numberK122647
Submission
- Device name
- Synthes Patient Specific Plate
- Applicant
- Synthes, Inc.
West Chester, PA, US - Received
- August 30, 2012
- Decision date
- February 28, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K131792 | Synthecel Dura Repair, Synthecel Dura OnlayGXQ · Traditional | 12/16/2013SE |
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Questions and answers
When was Synthes Patient Specific Plate cleared by the FDA?
Synthes Patient Specific Plate (K122647) received a 510(k) decision of Substantially Equivalent on February 28, 2013, 182 days after the submission was received.
What is the product code of K122647?
The FDA product code is JEY – Plate, Bone, a Class II (moderate risk) device regulated under 21 CFR 872.4760.