The following data is part of a premarket notification filed by Joimax Gmbh with the FDA for Endolif Delta-cage And Doublewedge-cage.
| Device ID | K203014 |
| 510k Number | K203014 |
| Device Name: | EndoLIF Delta-Cage And DoubleWedge-Cage |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | joimax GmbH Amalienbadstrasse 41 Raumfabrik 61, DE 76227 |
| Contact | Gary Mocnik |
| Correspondent | Gary Mocnik Gary Mocnik And Associates 49 Coastal Oak Aliso Viejo, CA 92656 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-10-01 |
| Decision Date | 2021-09-01 |