The following data is part of a premarket notification filed by Spinevision, S.a. with the FDA for Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.l.i.s. Pedicle Screw Fixation System.
| Device ID | K133575 |
| 510k Number | K133575 |
| Device Name: | SPINEVISION LUMIS CANNULATED PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S. PEDICLE SCREW FIXATION SYSTEM |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | SPINEVISION, S.A. Antony Parc II 10 Place Du General De Gaulle Antony Cedex, FR 92184 |
| Contact | J.d. Webb |
| Correspondent | J.d. Webb SPINEVISION, S.A. Antony Parc II 10 Place Du General De Gaulle Antony Cedex, FR 92184 |
| Product Code | MNH |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-20 |
| Decision Date | 2014-06-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03663136018782 | K133575 | 000 |
| 03663136003306 | K133575 | 000 |
| 03663136003443 | K133575 | 000 |
| 03663136003573 | K133575 | 000 |
| 03663136003702 | K133575 | 000 |
| 03663136003788 | K133575 | 000 |
| 03663136007670 | K133575 | 000 |
| 03663136007809 | K133575 | 000 |
| 03663136017044 | K133575 | 000 |
| 03663136002996 | K133575 | 000 |