The following data is part of a premarket notification filed by Kelyniam Global, Inc. with the FDA for Custom Craniofacial Implant (cci).
| Device ID | K121755 |
| 510k Number | K121755 |
| Device Name: | CUSTOM CRANIOFACIAL IMPLANT (CCI) |
| Classification | Plate, Cranioplasty, Preformed, Non-alterable |
| Applicant | KELYNIAM GLOBAL, INC. 97 River Rd STE A Canton, CT 06019 |
| Contact | Nicholas Breault |
| Correspondent | Nicholas Breault KELYNIAM GLOBAL, INC. 97 River Rd STE A Canton, CT 06019 |
| Product Code | GXN |
| CFR Regulation Number | 882.5330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-15 |
| Decision Date | 2012-09-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817580021488 | K121755 | 000 |