510(k) K172214
K172214 is an FDA 510(k) premarket notification submitted by G-21 S.R.L. for the device "Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters". The FDA issued a decision of Substantially Equivalent on Aug 23, 2017. 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
- Aug 23, 2017
- Date Received
- Jul 24, 2017
- Clearance Type
- Special
- 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)