The following data is part of a premarket notification filed by Signus Medizintechnik Gmbh with the FDA for Mobis Ii.
| Device ID | K131372 |
| 510k Number | K131372 |
| Device Name: | MOBIS II |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | SIGNUS MEDIZINTECHNIK GMBH PO BOX 566 Chesterland, OH 44026 -2141 |
| Contact | Karen E Warden |
| Correspondent | Karen E Warden SIGNUS MEDIZINTECHNIK GMBH PO BOX 566 Chesterland, OH 44026 -2141 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-13 |
| Decision Date | 2013-07-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04047844015902 | K131372 | 000 |
| 04047844015780 | K131372 | 000 |
| 04047844015773 | K131372 | 000 |
| 04047844015766 | K131372 | 000 |
| 04047844015759 | K131372 | 000 |
| 04047844015742 | K131372 | 000 |
| 04047844015735 | K131372 | 000 |
| 04047844015728 | K131372 | 000 |
| 04047844015711 | K131372 | 000 |
| 04047844015704 | K131372 | 000 |
| 04047844015698 | K131372 | 000 |
| 04047844015681 | K131372 | 000 |
| 04047844015797 | K131372 | 000 |
| 04047844015896 | K131372 | 000 |
| 04047844015889 | K131372 | 000 |
| 04047844015872 | K131372 | 000 |
| 04047844015865 | K131372 | 000 |
| 04047844015858 | K131372 | 000 |
| 04047844015841 | K131372 | 000 |
| 04047844015834 | K131372 | 000 |
| 04047844015827 | K131372 | 000 |
| 04047844015810 | K131372 | 000 |
| 04047844015803 | K131372 | 000 |
| 04047844015667 | K131372 | 000 |
| 04047844015919 | K131372 | 000 |
| 04047844015674 | K131372 | 000 |