Prebent Plating with Virtual Surgical Planning
FDA 510(k) K131674 · Biomet Microfixation
510(k) numberK131674
Submission
- Device name
- Prebent Plating with Virtual Surgical Planning
- Applicant
- Biomet Microfixation
Jacksonville, FL, US - Received
- June 7, 2013
- Decision date
- August 8, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Prebent Plating with Virtual Surgical Planning cleared by the FDA?
Prebent Plating with Virtual Surgical Planning (K131674) received a 510(k) decision of Substantially Equivalent on August 8, 2013, 62 days after the submission was received.
What is the product code of K131674?
The FDA product code is JEY – Plate, Bone, a Class II (moderate risk) device regulated under 21 CFR 872.4760.