510(k) K160707
K160707 is an FDA 510(k) premarket notification submitted by Fin-Ceramica Faenza S.P.A. for the device "CustomizedBone Service". The FDA issued a decision of Substantially Equivalent on December 17, 2016. The device falls under product code GXN (Plate, Cranioplasty, Preformed, Non-Alterable), a Class II device regulated under 21 CFR 882.5330. Fin-Ceramica Faenza S.P.A. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 17, 2016
- Date Received
- March 14, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plate, Cranioplasty, Preformed, Non-Alterable
- Device Class
- Class II
- Regulation Number
- 882.5330
- Review Panel
- NE
- Submission Type