The following data is part of a premarket notification filed by Spinevision, S.a. with the FDA for Spinevision Lumis(tm) Cannulated Polyaxial Pedicle Screw Fixation System, Spinevision U.l.i.s.(tm) Polyaxial Pedicle ....
| Device ID | K112607 |
| 510k Number | K112607 |
| Device Name: | SPINEVISION LUMIS(TM) CANNULATED POLYAXIAL PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S.(TM) POLYAXIAL PEDICLE ... |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | SPINEVISION, S.A. 111 HILL ROAD Douglassville, PA 19518 |
| Contact | Donald W Guthner |
| Correspondent | Donald W Guthner SPINEVISION, S.A. 111 HILL ROAD Douglassville, PA 19518 |
| Product Code | NKB |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-07 |
| Decision Date | 2012-06-07 |
| Summary: | summary |