Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K182711
Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI) · Kelyniam Global, Inc. · decided 2019-05-21 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| CUSTOMIZED SKULL IMPLANT (CSI) | PEEK-IM1001 | KELYNIAM GLOBAL, INC. | GWO | 00810125929502 |
| CUSTOMIZED SKULL IMPLANT (CSI) | PEEK-IM1004 | KELYNIAM GLOBAL, INC. | GWO | 00810125929519 |
| CUSTOMIZED SKULL IMPLANT (CSI) | PEEK-IM1003 | KELYNIAM GLOBAL, INC. | GWO | 00810125929595 |
| CUSTOMIZED SKULL IMPLANT (CSI) | PEEK-IM1002 | KELYNIAM GLOBAL, INC. | GWO | 00810125929472 |
| CUSTOMIZED SKULL IMPLANT (CSI) | PEEK-IM1004 | KELYNIAM GLOBAL, INC. | GWO | 00810125929526 |
| CUSTOMIZED SKULL IMPLANT (CSI) | PEEK-IM1004 | KELYNIAM GLOBAL, INC. | GWO | 00810125929434 |
| CUSTOMIZED SKULL IMPLANT (CSI) | PEEK-IM1004 | KELYNIAM GLOBAL, INC. | GWO | 00810125929458 |
| CUSTOMIZED SKULL IMPLANT (CSI) | PEEK-IM1004 | KELYNIAM GLOBAL, INC. | GWO | 00810125929441 |
| CUSTOMIZED SKULL IMPLANT (CSI) | PEEK-IM1004 | KELYNIAM GLOBAL, INC. | GWO | 00810125929533 |
| CUSTOMIZED SKULL IMPLANT (CSI) | PEEK-IM1004 | KELYNIAM GLOBAL, INC. | GWO | 00810125929557 |
| CUSTOMIZED SKULL IMPLANT (CSI) | PEEK-IM1004 | KELYNIAM GLOBAL, INC. | GWO | 00810125929465 |
| CUSTOMIZED SKULL IMPLANT (CSI) | PEEK-IM1004 | KELYNIAM GLOBAL, INC. | GWO | 00810125929601 |
| CUSTOMIZED SKULL IMPLANT (CSI) | PEEK-IM1004 | KELYNIAM GLOBAL, INC. | GWO | 00810125929496 |
| CUSTOMIZED SKULL IMPLANT (CSI) | PEEK-IM1001 | KELYNIAM GLOBAL, INC. | GWO | 00810125929540 |
| CUSTOMIZED SKULL IMPLANT (CSI) | PEEK-IM1004 | KELYNIAM GLOBAL, INC. | GWO | 00810125929427 |
| CUSTOMIZED SKULL IMPLANT (CSI) | PEEK-IM1004 | KELYNIAM GLOBAL, INC. | GWO | 00810125929564 |
| CUSTOMIZED SKULL IMPLANT (CSI) | PEEK-IM1004 | KELYNIAM GLOBAL, INC. | GWO | 00810125929489 |
| CUSTOMIZED SKULL IMPLANT (CSI) | PEEK-IM1001 | KELYNIAM GLOBAL, INC. | GWO | 00810125929588 |
| CUSTOMIZED SKULL IMPLANT (CSI) | PEEK-IM1004 | KELYNIAM GLOBAL, INC. | GWO | 00810125929571 |
| CUSTOMIZED SKULL IMPLANT (CSI) | PEEK-IM1004 | KELYNIAM GLOBAL, INC. | GWO | 00810125929687 |
| CUSTOMIZED SKULL IMPLANT (CSI) | PEEK-IM1004 | KELYNIAM GLOBAL, INC. | GWO | 00810125929731 |
| CUSTOMIZED SKULL IMPLANT (CSI) | PEEK-IM1004 | KELYNIAM GLOBAL, INC. | GWO | 00810125929663 |
| CUSTOMIZED SKULL IMPLANT (CSI) | PEEK-IM1004 | KELYNIAM GLOBAL, INC. | GWO | 00810125929823 |
| CUSTOMIZED SKULL IMPLANT (CSI) | PEEK-IM1004 | KELYNIAM GLOBAL, INC. | GWO | 00810125929816 |
| CUSTOMIZED SKULL IMPLANT (CSI) | PEEK-IM1004 | KELYNIAM GLOBAL, INC. | GWO | 00810125929694 |