The following data is part of a premarket notification filed by Kisco International with the FDA for Odalys Pedicle Screw System.
| Device ID | K152098 |
| 510k Number | K152098 |
| Device Name: | ODALYS Pedicle Screw System |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | Kisco International 2 Place Berthe Morisot Saint-priest, FR 69800 |
| Contact | Hiroko Ito |
| Correspondent | Rich Jansen RICH JANSEN, PHARM. D. 11821 BRAMBLE COVE DRIVE Fort Myers, FL 33905 |
| Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-28 |
| Decision Date | 2015-09-17 |
| Summary: | summary |