Stryker Ivas Balloon Catheter
FDA 510(k) K123942 · Stryker Corporation
510(k) numberK123942
Submission
- Device name
- Stryker Ivas Balloon Catheter
- Applicant
- Stryker Corporation
Kalamazoo, MI, US - Received
- December 20, 2012
- Decision date
- April 3, 2013
- 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 Stryker Ivas Balloon Catheter cleared by the FDA?
Stryker Ivas Balloon Catheter (K123942) received a 510(k) decision of Substantially Equivalent on April 3, 2013, 104 days after the submission was received.
What is the product code of K123942?
The FDA product code is NDN – Cement, Bone, Vertebroplasty, a Class II (moderate risk) device regulated under 21 CFR 888.3027.