Tristar Bone Graft Fixation System
FDA 510(k) K141764 · Impladent , Ltd.
510(k) numberK141764
Submission
- Device name
- Tristar Bone Graft Fixation System
- Applicant
- Impladent , Ltd.
Hollis, NY, US - Received
- July 1, 2014
- Decision date
- December 18, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Tristar Bone Graft Fixation System cleared by the FDA?
Tristar Bone Graft Fixation System (K141764) received a 510(k) decision of Substantially Equivalent on December 18, 2014, 170 days after the submission was received.
What is the product code of K141764?
The FDA product code is JEY – Plate, Bone, a Class II (moderate risk) device regulated under 21 CFR 872.4760.