Radiopaque Bone Cement
FDA 510(k) K043518 · Cardinalhealth
510(k) numberK043518
Submission
- Device name
- Radiopaque Bone Cement
- Applicant
- Cardinalhealth
Mcgaw Park, IL, US - Received
- December 20, 2004
- Decision date
- May 11, 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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Questions and answers
When was Radiopaque Bone Cement cleared by the FDA?
Radiopaque Bone Cement (K043518) received a 510(k) decision of Substantially Equivalent on May 11, 2005, 142 days after the submission was received.
What is the product code of K043518?
The FDA product code is NDN – Cement, Bone, Vertebroplasty, a Class II (moderate risk) device regulated under 21 CFR 888.3027.