The following data is part of a premarket notification filed by Industrias Medicas Sampedro S.a.s. with the FDA for Techfit Patient-specific Maxillofacial System.
| Device ID | K203282 |
| 510k Number | K203282 |
| Device Name: | TECHFIT Patient-Specific Maxillofacial System |
| Classification | Plate, Bone |
| Applicant | Industrias Medicas Sampedro S.A.S. Carrera 47 N 100 Sur 40 Centro Industrial Portal Del Sur Bodega 14 La Estrella, CO 055468 |
| Contact | Leidy Johanna Toro Gonzalez |
| Correspondent | Leidy Johanna Toro Gonzalez Industrias Medicas Sampedro S.A.S. Carrera 47 N 100 Sur 40 Centro Industrial Portal Del Sur Bodega 14 La Estrella, CO 055468 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-06 |
| Decision Date | 2021-05-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860007543449 | K203282 | 000 |
| 00860007543425 | K203282 | 000 |
| 00860007543401 | K203282 | 000 |
| 00860007543418 | K203282 | 000 |