The following data is part of a premarket notification filed by 3d-shaper Medical S.l with the FDA for 3d-shaper.
| Device ID | K220822 |
| 510k Number | K220822 |
| Device Name: | 3D-SHAPER |
| Classification | Densitometer, Bone |
| Applicant | 3D-Shaper Medical S.L C/ Paris 179, 2-2 Barcelona, ES 08036 |
| Contact | Ludovic Humbert |
| Correspondent | Ludovic Humbert 3D-Shaper Medical S.L C/ Paris 179, 2-2 Barcelona, ES 08036 |
| Product Code | KGI |
| CFR Regulation Number | 892.1170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-21 |
| Decision Date | 2022-12-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08437021740028 | K220822 | 000 |