Mini and Micro Fragments Reconstruction System-Neoface
FDA 510(k) K102641 · Neoortho Produtos Ortopedicos S/A
510(k) numberK102641
Submission
- Device name
- Mini and Micro Fragments Reconstruction System-Neoface
- Applicant
- Neoortho Produtos Ortopedicos S/A
San Diego, CA, US - Received
- September 13, 2010
- Decision date
- December 20, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Mini and Micro Fragments Reconstruction System-Neoface cleared by the FDA?
Mini and Micro Fragments Reconstruction System-Neoface (K102641) received a 510(k) decision of Substantially Equivalent on December 20, 2010, 98 days after the submission was received.
What is the product code of K102641?
The FDA product code is JEY – Plate, Bone, a Class II (moderate risk) device regulated under 21 CFR 872.4760.