CustomizedBone Service
Plate, Cranioplasty, Preformed, Non-alterable
Fin-Ceramica Faenza S.p.A
The following data is part of a premarket notification filed by Fin-ceramica Faenza S.p.a with the FDA for Customizedbone Service.
Pre-market Notification Details
| Device ID | K180513 |
| 510k Number | K180513 |
| Device Name: | CustomizedBone Service |
| Classification | Plate, Cranioplasty, Preformed, Non-alterable |
| Applicant | Fin-Ceramica Faenza S.p.A via Ravegnana 186 Faenza, IT 48018 |
| Contact | Marina Monticelli |
| Correspondent | Mary Beth Henderson Regulatory And Clinical Research Institute, Inc. 5353 Wayzata Blvd, Suite 505 Minneapolis, MN 55416 |
| Product Code | GXN |
| CFR Regulation Number | 882.5330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-27 |
| Decision Date | 2018-05-15 |
Trademark Results [CustomizedBone Service]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CUSTOMIZEDBONE SERVICE 86326625 5291349 Live/Registered |
Fin-Ceramica Faenza S.p.A. 2014-07-02 |
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