The following data is part of a premarket notification filed by Joimax Gmbh with the FDA for Endolif On-cage.
| Device ID | K151143 |
| 510k Number | K151143 |
| Device Name: | EndoLIF On-Cage |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | JOIMAX GMBH AMALIENBADSTRASSE 41 Raumfabrik 61 Karlsruhe, DE 76227 |
| Contact | Eulodie Tila |
| Correspondent | Gary Mocnik Gary S. 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 | 2015-04-29 |
| Decision Date | 2015-07-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04250337113133 | K151143 | 000 |
| 04250337106319 | K151143 | 000 |
| 04250337106302 | K151143 | 000 |
| 04250337106296 | K151143 | 000 |
| 04250337106289 | K151143 | 000 |
| 04250337106272 | K151143 | 000 |
| 04250337106265 | K151143 | 000 |
| 04250337106258 | K151143 | 000 |
| 04250337106241 | K151143 | 000 |
| 04250337106234 | K151143 | 000 |
| 04250337106227 | K151143 | 000 |
| 04250337106210 | K151143 | 000 |
| 04250337106203 | K151143 | 000 |
| 04250337106197 | K151143 | 000 |
| 04250337106326 | K151143 | 000 |
| 04250337107545 | K151143 | 000 |
| 04250337113126 | K151143 | 000 |
| 04250337113119 | K151143 | 000 |
| 04250337111092 | K151143 | 000 |
| 04250337111085 | K151143 | 000 |
| 04250337111078 | K151143 | 000 |
| 04250337107620 | K151143 | 000 |
| 04250337107613 | K151143 | 000 |
| 04250337107606 | K151143 | 000 |
| 04250337107590 | K151143 | 000 |
| 04250337107583 | K151143 | 000 |
| 04250337107576 | K151143 | 000 |
| 04250337107569 | K151143 | 000 |
| 04250337107552 | K151143 | 000 |
| 04250337105923 | K151143 | 000 |