510(k) K133669
K133669 is an FDA 510(k) premarket notification submitted by Imedicom for the device "MEDINAUT KYPHOPLASTY SYSTEM". The FDA issued a decision of Substantially Equivalent on Apr 4, 2014. The device falls under product code NDN (Cement, Bone, Vertebroplasty), a Class II device regulated under 21 CFR 888.3027.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 4, 2014
- Date Received
- Nov 29, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Cement, Bone, Vertebroplasty
- Device Class
- Class II
- Regulation Number
- 888.3027
- Review Panel
- OR
- Submission Type
- 510(k)