Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K153633
Endoform Reconstructive Template · Aroa Biosurgery Limited (Formerly Mesynthes Limited) · decided 2016-03-15 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| OviTex® 1S | F10256-1020G | AROA BIOSURGERY LIMITED | FTM | 09421904065314 |
| OviTex® 1S | F10256-0408G | AROA BIOSURGERY LIMITED | FTM | 09421904065284 |
| OviTex® 2S | F10258-0408G | AROA BIOSURGERY LIMITED | FTM | 09421904065352 |
| OviTex® 2S | F10258-1012G | AROA BIOSURGERY LIMITED | FTM | 09421904065376 |
| OviTex® Core | F10254-2020G | AROA BIOSURGERY LIMITED | FTM | 09421904065277 |
| OviTex® Core | F10254-1620G | AROA BIOSURGERY LIMITED | FTM | 09421904065253 |
| OviTex® 2S | F10258-1020G | AROA BIOSURGERY LIMITED | FTM | 09421904065383 |
| OviTex® 1S | F10256-1012G | AROA BIOSURGERY LIMITED | FTM | 09421904065307 |
| OviTex® 1S | F10256-0610G | AROA BIOSURGERY LIMITED | FTM | 09421904065291 |
| OviTex® 1S | F10256-1822G | AROA BIOSURGERY LIMITED | FTM | 09421904065338 |
| OviTex® Core | F10254-0610G | AROA BIOSURGERY LIMITED | FTM | 09421904065222 |
| OviTex® Core | F10254-1020G | AROA BIOSURGERY LIMITED | FTM | 09421904065246 |
| OviTex® 2S | F10258-1822G | AROA BIOSURGERY LIMITED | FTM | 09421904065406 |
| OviTex® 2S | F10258-1620G | AROA BIOSURGERY LIMITED | FTM | 09421904065390 |
| OviTex® Core | F10254-1822G | AROA BIOSURGERY LIMITED | FTM | 09421904065260 |
| OviTex® 1S | F10256-1620G | AROA BIOSURGERY LIMITED | FTM | 09421904065321 |
| OviTex® Core | F10254-1012G | AROA BIOSURGERY LIMITED | FTM | 09421904065239 |
| OviTex® Core | F10254-0408G | AROA BIOSURGERY LIMITED | FTM | 09421904065215 |
| OviTex® 2S | F10258-0610G | AROA BIOSURGERY LIMITED | FTM | 09421904065369 |
| OviTex® 2S | F10258-2020G | AROA BIOSURGERY LIMITED | FTM | 09421904065413 |
| OviTex® 1S | F10256-2020G | AROA BIOSURGERY LIMITED | FTM | 09421904065345 |