The following data is part of a premarket notification filed by Medicrea International S.a. with the FDA for Ib3d Alif.
| Device ID | K191134 |
| 510k Number | K191134 |
| Device Name: | IB3D ALIF |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Medicrea International S.A. 5389, Route De Strasbourg Rillieux-la-pape, FR 69140 |
| Contact | David Ryan |
| Correspondent | David Ryan Medicrea International S.A. 5389 Route De Strasbourg - Vancia Rillieux-la-pape, FR 69140 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-29 |
| Decision Date | 2019-10-30 |
| Summary: | summary |