Vertebroplastic Radiopaque Bone Cement
FDA 510(k) K043406 · Depuy Spine, Inc.
510(k) numberK043406
Submission
- Device name
- Vertebroplastic Radiopaque Bone Cement
- Applicant
- Depuy Spine, Inc.
Raynham, MA, US - Received
- December 10, 2004
- Decision date
- July 15, 2005
- 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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| K110216 | Expedium System, Viper SystemNKB · Special | 04/01/2011SE |
| K103133 | Veper System, Expedium SystemNKB · Special | 01/18/2011SE |
| K101993 | Viper System, Expedium SystemNKB · Special | 12/07/2010SE |
| K101923 | Concorde Curve SystemMAX · Special | 12/01/2010SE |
Questions and answers
When was Vertebroplastic Radiopaque Bone Cement cleared by the FDA?
Vertebroplastic Radiopaque Bone Cement (K043406) received a 510(k) decision of Substantially Equivalent on July 15, 2005, 217 days after the submission was received.
What is the product code of K043406?
The FDA product code is NDN – Cement, Bone, Vertebroplasty, a Class II (moderate risk) device regulated under 21 CFR 888.3027.