510(k) K180513
K180513 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 May 15, 2018. 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
- May 15, 2018
- Date Received
- February 27, 2018
- 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