510(k) K163032
K163032 is an FDA 510(k) premarket notification submitted by Medtronic, Inc. for the device "Kyphon Xpede Bone Cement". The FDA issued a decision of Substantially Equivalent on Feb 27, 2017. The device falls under product code NDN (Cement, Bone, Vertebroplasty), a Class II device regulated under 21 CFR 888.3027. Medtronic, Inc. has 247 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 27, 2017
- Date Received
- Oct 31, 2016
- 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)