The following data is part of a premarket notification filed by Spineart with the FDA for Otelo Ll.
| Device ID | K151104 |
| 510k Number | K151104 |
| Device Name: | OTELO LL |
| Classification | Retractor |
| Applicant | SPINEART INTERNATIONAL CENTER COINTRIN 20 ROUTE DE PRE-BOIS, CP1813 Geneve, CH 1215 |
| Contact | Franck Pennesi |
| Correspondent | Franck Pennesi SPINEART INTERNATIONAL CENTER COINTRIN 20 ROUTE DE PRE-BOIS, CP1813 Geneve, CH 1215 |
| Product Code | GAD |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-24 |
| Decision Date | 2016-01-06 |
| Summary: | summary |