Kyph X Hv-R Bone Cement
FDA 510(k) K093828 · Medtronic, Inc.
510(k) numberK093828
Submission
- Device name
- Kyph X Hv-R Bone Cement
- Applicant
- Medtronic, Inc.
Sunnyvale, CA, US - Received
- December 14, 2009
- Decision date
- August 12, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 Kyph X Hv-R Bone Cement cleared by the FDA?
Kyph X Hv-R Bone Cement (K093828) received a 510(k) decision of Substantially Equivalent on August 12, 2010, 241 days after the submission was received.
What is the product code of K093828?
The FDA product code is NDN – Cement, Bone, Vertebroplasty, a Class II (moderate risk) device regulated under 21 CFR 888.3027.