Inflatable Bone Tamp
FDA 510(k) K090211 · Cardinal Health, Inc.
510(k) numberK090211
Submission
- Device name
- Inflatable Bone Tamp
- Applicant
- Cardinal Health, Inc.
Mcgaw Park, IL, US - Received
- January 28, 2009
- Decision date
- July 1, 2009
- 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 Inflatable Bone Tamp cleared by the FDA?
Inflatable Bone Tamp (K090211) received a 510(k) decision of Substantially Equivalent on July 1, 2009, 154 days after the submission was received.
What is the product code of K090211?
The FDA product code is NDN – Cement, Bone, Vertebroplasty, a Class II (moderate risk) device regulated under 21 CFR 888.3027.