Hexanium PLIF
Spinevision, S.A.S.
SPINEVISION INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3025457095 | 3025457095 | SPINEVISION INC. | 1 | Y | 2026-01-01 | 3321 Towerwood Dr Ste 130 Farmers Branch TX US 75234 |
| 1067145 | 3010321861 | SPINEVISION, INC. | 1 | Y | 2020-04-25 | 185 Alewife Brook Pkwy Ste 402 Cambridge MA US 02138 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 312575 | 1222649278 | K223251 | Hexanium PLIF | MAX | 2022-12-16 |
| 312575 | 1170757977 | K221578 | Hexanium ACIF | OVE | 2022-11-14 |
| 312575 | 1070328615 | K210359 | Hexanium TLIF | MAX | 2021-03-10 |
| 312575 | 1311391409 | K193000 | Hexanium® ACIF | OVE | 2020-10-20 |
| 312575 | 1575301288 | K180437 | Hexanium® TLIF | MAX | 2018-05-04 |
| 312575 | 1892712334 | K160124 | LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System | MNI | 2016-04-04 |
| 312575 | 1386414565 | K153783 | SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIF | MAX | 2016-05-04 |
| 312575 | 1742749525 | K133575 | SPINEVISION LUMIS CANNULATED PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S. PEDICLE SCREW FIXATION SYSTEM | MNH | 2014-06-30 |
| 312575 | 1461993281 | K130302 | SPINEVISION LUMIS CANNULATED POLYAXIAL PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S. POLYAXIAL PEDICLE SCREW FIXAT | MNI | 2013-07-30 |
| 312575 | 1025936632 | K112607 | SPINEVISION LUMIS(TM) CANNULATED POLYAXIAL PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S.(TM) POLYAXIAL PEDICLE ... | NKB | 2012-06-07 |
| 312575 | 1889876382 | K052406 | UNI-THREAD SPINAL SYSTEM | MNI | 2005-11-07 |
| 312575 | 1689290061 | K042930 | SPACEVISION CAGE SYSTEM | MQP | 2004-12-28 |
| 312575 | 1369310395 | K042640 | UNI-THREAD SPINAL SYSTEM | MNH | 2004-11-23 |
| 312575 | 1328407942 | K033508 | PLUS PIVOT LINK UNIVERSAL SYSTEM | MNI | 2004-01-27 |
| 312575 | 1367195211 | K032398 | PLUS PIVOT LINK UNIVERSAL SYSTEM | MNI | 2003-10-31 |
| 312575 | 1631328868 | K022271 | PLUS PIVOT LINK UNIVERSAL SYSTEM | MNI | 2002-09-23 |
| 312575 | 1699339193 | K021510 | UNI-T UNI-THREAD SPINAL SYSTEM | MNI | 2002-08-01 |
| 312575 | 1095666631 | K021507 | PLUS PIVOT LINK UNIVERSAL SYSTEM | KWP | 2002-08-01 |
| 312575 | 1423005877 | K013312 | P.L.U.S. SYSTEM (PIVOT LINK UNIVERSAL SYSTEM) | KWP | 2002-02-13 |
| 312575 | 1327506600 | K013301 | UNI-T SPINAL SYSTEM | MNI | 2002-02-13 |
| 312575 | 1713611460 | K012881 | C3 ANTERIOR CERVICAL PLATE SYSTEM | KWQ | 2001-11-26 |
| 312575 | 1022749674 | ||||
| 312575 | 1054716124 | ||||
| 312575 | 1064541381 | ||||
| 312575 | 1072347730 | ||||
| 312575 | 1089628071 | ||||
| 312575 | 1115173251 | ||||
| 312575 | 1168733594 | ||||
| 312575 | 1191482664 | ||||
| 312575 | 1248026261 | ||||
| 312575 | 1259911058 | ||||
| 312575 | 1334582364 | ||||
| 312575 | 1335628234 | ||||
| 312575 | 1349839035 | ||||
| 312575 | 1495845824 | ||||
| 312575 | 1672521580 | ||||
| 312575 | 1702184808 | ||||
| 312575 | 1754646276 | ||||
| 312575 | 1804435611 | ||||
| 312575 | 1858564884 | ||||
| 312575 | 1879971638 | ||||
| 312575 | 1924670929 | ||||
| 312575 | 1957895654 | ||||
| 312575 | 1964326577 | ||||
| 312575 | 2000883393 | ||||
| 312575 | 2073602278 |
Product Codes Associated With Registrations#
PMN#
Hexanium ACIF
Spinevision, S.A.S.
Hexanium TLIF
SpineVision SAS
Hexanium® ACIF
SpineVision SAS
Hexanium® TLIF
SpineVision, SAS
SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIF
SpineVision S.A.
LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System
SpineVision S.A.
SPINEVISION LUMIS CANNULATED PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S. PEDICLE SCREW FIXATION SYSTEM
SPINEVISION, S.A.
SPINEVISION LUMIS CANNULATED POLYAXIAL PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S. POLYAXIAL PEDICLE SCREW FIXAT
SPINEVISION, S.A.
SPINEVISION LUMIS(TM) CANNULATED POLYAXIAL PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S.(TM) POLYAXIAL PEDICLE ...
SPINEVISION, S.A.
PEDIGUARD NERVE DETECTOR SYSTEM
SPINEVISION, INC.
SPACEVISION CAGE SYSTEM
SPINEVISION, INC.
UNI-THREAD SPINAL SYSTEM
SPINEVISION, INC.
PLUS PIVOT LINK UNIVERSAL SYSTEM
SPINEVISION, INC.
PLUS PIVOT LINK UNIVERSAL SYSTEM
SPINEVISION, INC.
PLUS PIVOT LINK UNIVERSAL SYSTEM
SPINEVISION, INC.
P.L.U.S. SYSTEM (PIVOT LINK UNIVERSAL SYSTEM)
SPINEVISION, INC.
UNI-T SPINAL SYSTEM
SPINEVISION, INC.
GUDID#
C3® ACPS - 26.5 mm plate with SLS
2015-10-15
C3® ACPS - 26,5mm 1 LEVEL PLATE WITH SLS
2015-10-15
C3® ACPS - 29 mm plate with SLS
2015-10-15
C3® ACPS - 31,5mm 1 LEVEL PLATE WITH SLS
2015-10-15
C3® ACPS - 36.5 mm plate with SLS
2015-10-15
C3® ACPS - 54 mm plate with SLS, pin hole
2015-10-15
C3® ACPS - 69 mm plate with SLS
2015-10-15
C3® ACPS - 89 mm plate with SLS
2015-10-15
C3® ACPS - 105 mm plate with SLS
2015-10-15
C3® ACPS - Spring locking system for 39 plate
2015-10-15
C3® ACPS - Spring locking system for 57 plate
2015-10-15
C3® ACPS - 21.5 mm plate with SLS
2015-10-15
C3® ACPS - 21,5mm 1 LEVEL PLATE WITH SLS
2015-10-15
C3® ACPS - 24 mm plate with SLS
2015-10-15
C3® ACPS - 24mm 1 LEVEL PLATE WITH SLS
2015-10-15
C3® ACPS - 29mm 1 LEVEL PLATE WITH SLS
2015-10-15
C3® ACPS - 34 mm plate with SLS
2015-10-15
C3® ACPS - 34mm 1 LEVEL PLATE WITH SLS
2015-10-15
C3® ACPS - 36,5mm 1 LEVEL PLATE WITH SLS
2015-10-15
C3® ACPS - 39 mm plate with SLS
2015-10-15
C3® ACPS - 41.5 mm plate with SLS
2015-10-15
C3® ACPS - 41.5 mm plate with SLS, pin hole
2015-10-15
C3® ACPS - 44 mm plate with SLS
2015-10-15
C3® ACPS - 44 mm plate with SLS, pin hole
2015-10-15
C3® ACPS - 46.5 mm plate with SLS
2015-10-15
C3® ACPS - 46.5 mm plate with SLS, pin hole
2015-10-15
C3® ACPS - 49 mm plate with SLS, pin hole
2015-10-15
C3® ACPS - 51.5 mm plate with SLS
2015-10-15
C3® ACPS - 51.5 mm plate with SLS, pin hole
2015-10-15
C3® ACPS - 54 mm plate with SLS
2015-10-15
C3® ACPS - 56.5 mm plate with SLS
2015-10-15
C3® ACPS - 56.5 mm plate with SLS, pin hole
2015-10-15
C3® ACPS - 54 mm plate with SLS
2015-10-15
C3® ACPS - 57 mm plate with SLS
2015-10-15
C3® ACPS - 60 mm plate with SLS
2015-10-15
C3® ACPS - 63 mm plate with SLS
2015-10-15
C3® ACPS - 66 mm plate with SLS
2015-10-15
C3® ACPS - 72 mm plate with SLS
2015-10-15
C3® ACPS - 75 mm plate with SLS
2015-10-15
C3® ACPS - 78 mm plate with SLS
2015-10-15