Avamax Vertebral Balloon Model VBS1010, VBS1015, VBS1020
FDA 510(k) K093463 · Care Fusion
510(k) numberK093463
Submission
- Device name
- Avamax Vertebral Balloon Model VBS1010, VBS1015, VBS1020
- Applicant
- Care Fusion
Waukegan, IL, US - Received
- November 6, 2009
- Decision date
- February 26, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NDN – Cement, Bone, Vertebroplasty
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3027
- Specialty
- Orthopedic
- Implant
- Yes
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Questions and answers
When was Avamax Vertebral Balloon Model VBS1010, VBS1015, VBS1020 cleared by the FDA?
Avamax Vertebral Balloon Model VBS1010, VBS1015, VBS1020 (K093463) received a 510(k) decision of Substantially Equivalent on February 26, 2010, 112 days after the submission was received.
What is the product code of K093463?
The FDA product code is NDN – Cement, Bone, Vertebroplasty, a Class II (moderate risk) device regulated under 21 CFR 888.3027.