Synthes Synflate Vertevral Balloon System
FDA 510(k) K130146 · Synthes (Usa), LLC
510(k) numberK130146
Submission
- Device name
- Synthes Synflate Vertevral Balloon System
- Applicant
- Synthes (Usa), LLC
West Chester, PA, US - Received
- January 22, 2013
- Decision date
- May 20, 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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| K112030 | Synthes Radial Head Prosthesis SystemKWI · Traditional | 06/19/2012SE |
| K120854 | Synthes Va LCP Ankle Trauma SystemHRS · Traditional | 06/18/2012SE |
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Questions and answers
When was Synthes Synflate Vertevral Balloon System cleared by the FDA?
Synthes Synflate Vertevral Balloon System (K130146) received a 510(k) decision of Substantially Equivalent on May 20, 2013, 118 days after the submission was received.
What is the product code of K130146?
The FDA product code is NDN – Cement, Bone, Vertebroplasty, a Class II (moderate risk) device regulated under 21 CFR 888.3027.