The following data is part of a premarket notification filed by Kelyniam Global Inc. with the FDA for Customized Craniofacial Implant (cci), Customized Skull Implant (csi).
| Device ID | K182711 |
| 510k Number | K182711 |
| Device Name: | Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI) |
| Classification | Plate, Cranioplasty, Preformed, Alterable |
| Applicant | Kelyniam Global Inc. 97 River Road, Suite A Canton, CT 06019 |
| Contact | Eric Boyea |
| Correspondent | Eric Boyea Kelyniam Global Inc. 97 River Road, Suite A Canton, CT 06019 |
| Product Code | GWO |
| CFR Regulation Number | 882.5320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-27 |
| Decision Date | 2019-05-21 |