Bonalive Granules and Bonalive Plates
FDA 510(k) K071937 · Vivoxid , Ltd.
510(k) numberK071937
Submission
- Device name
- Bonalive Granules and Bonalive Plates
- Applicant
- Vivoxid , Ltd.
Findley, MN, US - Received
- July 13, 2007
- Decision date
- October 19, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KKY – Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3500
- Specialty
- General, Plastic Surgery
- Implant
- Yes
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Questions and answers
When was Bonalive Granules and Bonalive Plates cleared by the FDA?
Bonalive Granules and Bonalive Plates (K071937) received a 510(k) decision of Substantially Equivalent on October 19, 2007, 98 days after the submission was received.
What is the product code of K071937?
The FDA product code is KKY – Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction, a Class II (moderate risk) device regulated under 21 CFR 878.3500.