Fracture/Reconstruction System (Traumaone)
FDA 510(k) K081067 · Biomet Microfixation, Inc.
510(k) numberK081067
Submission
- Device name
- Fracture/Reconstruction System (Traumaone)
- Applicant
- Biomet Microfixation, Inc.
Jacksonville, FL, US - Received
- April 15, 2008
- Decision date
- May 9, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Fracture/Reconstruction System (Traumaone) cleared by the FDA?
Fracture/Reconstruction System (Traumaone) (K081067) received a 510(k) decision of Substantially Equivalent on May 9, 2008, 24 days after the submission was received.
What is the product code of K081067?
The FDA product code is JEY – Plate, Bone, a Class II (moderate risk) device regulated under 21 CFR 872.4760.