The following data is part of a premarket notification filed by Spinevision, S.a. with the FDA for Spinevision Lumis Cannulated Polyaxial Pedicle Screw Fixation System, Spinevision U.l.i.s. Polyaxial Pedicle Screw Fixat.
| Device ID | K130302 |
| 510k Number | K130302 |
| Device Name: | SPINEVISION LUMIS CANNULATED POLYAXIAL PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S. POLYAXIAL PEDICLE SCREW FIXAT |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | SPINEVISION, S.A. ANTONY PARC II - 10 PLACE DU GENERAL DE GAULLE CS 70001 Antony Cedex, FR 92184 |
| Contact | Helene Plas |
| Correspondent | Helene Plas SPINEVISION, S.A. ANTONY PARC II - 10 PLACE DU GENERAL DE GAULLE CS 70001 Antony Cedex, FR 92184 |
| Product Code | MNI |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-07 |
| Decision Date | 2013-07-30 |
| Summary: | summary |