FDA Registration
Active
🇫🇷 France
SPINEVISION SAS
Reg #: 3003526896
·
FEI: 3003526896
·
Expires 2026
Products
33
Proprietary Names
254
Establishment Types
2
Classifications
33
Registration Details
- Registration Name
- SPINEVISION SAS
- Registration Number
- 3003526896
- FEI Number
- 3003526896
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 3 Rue De La Renaissance
- City
- Antony Hauts-de-Seine
- Country
- FR
Regulatory Submissions
- 510(k) Number
- K013312
Owner / Operator
- Firm Name
- SPINEVISION SAS
- Operator Number
- 9048013
- Address
- 3 rue de la Renaissance
- City
- Antony
- State
- Paris
- Postal Code
- F-92160
- Country
- FR
- Correspondent
- Quang TRAN
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2007-11-05 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2007-11-05 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2007-11-05 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2020-10-29 |
| Bender | HXW | Class 1 | Orthopedic | No | 2002-02-21 |
| Driver, Prosthesis | HWR | Class 1 | Orthopedic | No | 2002-02-21 |
| Holder, Needle; Orthopedic | HXK | Class 1 | Orthopedic | No | 2018-05-11 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2016-05-20 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2002-02-21 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2005-01-13 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2013-08-02 |
| Template | HWT | Class 1 | Orthopedic | No | 2002-02-21 |
| Hammer, Surgical | FZY | Class 1 | General, Plastic Surgery | No | 2005-01-13 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2005-01-13 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2002-02-21 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2012-06-20 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2002-02-21 |
| Wrench | HXC | Class 1 | Orthopedic | No | 2002-02-21 |
| Probe | HXB | Class 1 | Orthopedic | No | 2002-02-21 |
| Trephine | HWK | Class 1 | Orthopedic | No | 2002-02-21 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2002-02-21 |
| Tamp | HXG | Class 1 | Orthopedic | No | 2018-05-11 |
| Cutter, Wire | HXZ | Class 1 | Orthopedic | No | 2010-03-22 |
| Instrument, Cutting, Orthopedic | HTZ | Class 1 | General, Plastic Surgery | No | 2002-02-21 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2007-11-05 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2002-02-21 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2002-02-21 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 2002-02-21 |
| Spatula, Orthopedic | HXR | Class 1 | General, Plastic Surgery | No | 2002-02-21 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2005-01-13 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2002-02-21 |
| Pliers, Surgical | HTC | Class 1 | General, Plastic Surgery | No | 2002-02-21 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2002-02-21 |
Proprietary Names
PLUS Pivot Link Universal System
AC2-CSM10C_Convex Ti SA Cervical Cage
AC2-CSM08L_Lordotic Ti SA Cervical Cage
AC2-CSS12C_Convex Ti SA Cervical Cage
AC2-SD3512S_Self-Drilling Screws
AC2-SD3510S_Self-Drilling Screws
AC2-SD3514S_Self-Drilling Screws
AC2-SD3812S_Self-Drilling Screws
AC2-SD3814S_Self-Drilling Screws
AC2-CSL12C_Convex Ti SA Cervical Cage
AC2-CSS010C_Convex Ti SA Cervical Cage
AC2-CSL06C_Convex Ti SA Cervical Cage
AC2-CSL05C_Convex Ti SA Cervical Cage
AC2-CSL05L_Lordotic Ti SA Cervical Cage
AC2-CSM08C_Convex Ti SA Cervical Cage
AC2-CSS11C_Convex Ti SA Cervical Cage
AC2-CSS05C_Convex Ti SA Cervical Cage
AC2-CSL08L_Lordotic Ti SA Cervical Cage
AC2-SD3816S_Self-Drilling Screws
AC2-CSM06C_Convex Ti SA Cervical Cage
AC2-CSM05C_Convex Ti SA Cervical Cage
AC2-CSS05L_Lordotic Ti SA Cervical Cage
AC2-CSM10L_Lordotic Ti SA Cervical Cage
AC2-CSL06L_Lordotic Ti SA Cervical Cage
AC2-CSL08C_Convex Ti SA Cervical Cage
AC2-CSL10C_Convex Ti SA Cervical Cage
AC2-CSL10L_Lordotic Ti SA Cervical Cage
AC2-CSL07C_Convex Ti SA Cervical Cage
AC2-CSM11L_Lordotic Ti SA Cervical Cage
AC2-CSL09C_Convex Ti SA Cervical Cage
AC2-CSS09L_Lordotic Ti SA Cervical Cage
AC2-CSM09L_Lordotic Ti SA Cervical Cage
AC2-CSM06L_Lordotic Ti SA Cervical Cage
AC2-CSM12C_Convex Ti SA Cervical Cage
AC2-CSS06C_Convex Ti SA Cervical Cage
AC2-CSM11C_Convex Ti SA Cervical Cage
AC2-CSL12L_Lordotic Ti SA Cervical Cage
AC2-CSL11L_Lordotic Ti SA Cervical Cage
Hexanium® ACIF
AC2-CSM07C_Convex Ti SA Cervical Cage
AC2-CSS08C_Convex Ti SA Cervical Cage
AC2-CSS12L_Lordotic Ti SA Cervical Cage
AC2-CSM05L_Lordotic Ti SA Cervical Cage
AC2-CSL07L_Lordotic Ti SA Cervical Cage
AC2-SD3810S_Self-Drilling Screws
AC2-CSM12L_Lordotic Ti SA Cervical Cage
AC2-CSS09C_Convex Ti SA Cervical Cage
AC2-CSS11L_Lordotic Ti SA Cervical Cage
AC2-CSS07C_Convex Ti SA Cervical Cage
AC2-CSS010L_Lordotic Ti SA Cervical Cage
AC2-CSM09C_Convex Ti SA Cervical Cage
AC2-CSM07L_Lordotic Ti SA Cervical Cage
AC2-SD3516S_Self-Drilling Screws
AC2-CSL09L_Lordotic Ti SA Cervical Cage
AC2-CSL11C_Convex Ti SA Cervical Cage
AC2-CSS06L_Lordotic Ti SA Cervical Cage
AC2-CSS08L_Lordotic Ti SA Cervical Cage
AC2-CSS07L_Lordotic Ti SA Cervical Cage
SpineVision rod bender
PROSTHESIS (MULTIPLE BRANDS)
SpineVision Screw Driver
SpineVision Impactor
ULIS Universal Lumbar Intuitive System
LUMIS Lumbar Mini Invasive System
PL2-CS088
PL2-CS085
PL2-CM085
PL2-CS098
PL2-CS110
PL2-CM168
PL2-CS080
PL2-CS150
PL2-CS148
PL2-CS108
PL2-CM148
PL2-CS105
PL2-CS118
PL2-CM108
PL2-CM155
PL2-CM070
PL2-CM140
PL2-CM135
PL2-CS168
PL2-CS130
PL2-CM075
PL2-CS070
PL2-CM165
PL2-CM105
PL2-CM138
PL2-CS125
PL2-CS165
PL2-CS158
PL2-CM090
PL2-CS128
PL2-CM158
PL2-CM130
PL2-CM098
PL2-CM088
PL2-CM160
PL2-CS078
PL2-CM120
PL2-CS095
PL2-CM118
Hexanium® PLIF
PL2-CS135
PL2-CS138
PL2-CM150
PL2-CM125
PL2-CS115
PL2-CM095
PL2-CS120
PL2-CS075
PL2-CS090
PL2-CM100
PL2-CM145
PL2-CM128
PL2-CS100
PL2-CS155
PL2-CM080
PL2-CS145
PL2-CS140
PL2-CM110
PL2-CS160
PL2-CM078
PL2-CM115
TEMPLATE (MULTIPLE BRANDS)
SpineVision Surgical Hammer
SpineVision Reamer
AWL (MULTIPLE BRANDS)
ULIS Polyaxial Screw Fixation System
LUMIS Cannulated Polyaxial Screw Fixation System
DEPTH (MULTIPLE BRANDS)
WRENCH (MULTIPLE BRANDS)
P.L.U.S. System (Pivot Link Universal System)
PROBE (MULTIPLE BRANDS)
TREPHINE (MULTIPLE BRANDS)
UNI-Thread System
INSTRUMENT (MULTIPLE BRANDS)
FlexPLUS Smooth Cut Rod Cutter
ORTHOPEDIC (MULTIPLE BRANDS)
Uni-Thread Spinal System
Spacevision Cage System
C3 Anterior Cervical Plate System
BIT
DRILL (MULTIPLE BRANDS)
SpineVision Manual surgical instrument
AC2-CSS09L
AC2-CSS08C
AC2-SD3816S
AC2-CSM05C
AC2-CSM06L
AC2-CSS12L
AC2-CSS10L
AC2-CSL08L
AC2-CSM08L
AC2-CSL09L
AC2-CSL11C
AC2-CSS07C
AC2-SD3516S
AC2-CSL07L
AC2-CSM07L
AC2-CSL07C
AC2-CSM05L
AC2-CSM12C
AC2-CSL12C
AC2-CSL12L
AC2-CSM09C
AC2-CSS07L
AC2-CSM06C
AC2-CSM11L
AC2-SD3512S
AC2-CSL11L
AC2-CSM12L
AC2-CSM09L
AC2-CSS06C
AC2-CSM11C
AC2-CSS09C
AC2-CSS05C
AC2-CSS08L
AC2-CSS11L
AC2-CSL06L
AC2-SD3510S
AC2-CSL08C
AC2-CSL05L
AC2-SD3514S
AC2-CSM10C
AC2-CSS12C
AC2-CSS10C
AC2-CSS06L
AC2-CSM07C
AC2-SD3810S
AC2-CSL09C
AC2-CSL10L
AC2-CSL05C
AC2-SD3814S
AC2-CSM08C
AC2-CSL06C
AC2-CSL10C
AC2-CSS05L
AC2-CSS11C
AC2-SD3812S
AC2-CSM10L
Hexanium® TLIF
U.L.I.S. and LUMIS Pedicle Screw Fixation System (IS1-A317)
U.L.I.S. and LUMIS Pedicle Screw Fixation System (IS1-TRAY111)
U.L.I.S. and LUMIS Pedicle Screw Fixation System (IS1-ID)
U.L.I.S. and LUMIS Pedicle Screw Fixation System (IS1-TRAY115)
U.L.I.S. and LUMIS Pedicle Screw Fixation System (SD-RACK1)
U.L.I.S. and LUMIS Pedicle Screw Fixation System (IS1-TRAY114)
U.L.I.S. and LUMIS Pedicle Screw Fixation System (IS1-A316)
U.L.I.S. and LUMIS Pedicle Screw Fixation System (IS1-TRAY112)
PLUS Pivot Link Universal System (U1-L404T)
PLUS Pivot Link Universal System (U1-TRAY115)
PLUS Pivot Link Universal System (U1-L310T)
PLUS Pivot Link Universal System (U1-TRAY111)
PLUS Pivot Link Universal System (U1-ID)
PLUS Pivot Link Universal System (U1-L403T)
PLUS Pivot Link Universal System (U1-A216)
PLUS Pivot Link Universal System (U1-A328)
PLUS Pivot Link Universal System (U1-RACKVIS2)
PLUS Pivot Link Universal System (U1-A127C)
PLUS Pivot Link Universal System (SD-TRAY112)
PLUS Pivot Link Universal System (U1-TRAY117)
PLUS Pivot Link Universal System (U1-TRAY113)
PLUS Pivot Link Universal System (SD-A411LSH)
PLUS Pivot Link Universal System (SD-TRAY111)
PLUS Pivot Link Universal System (U1-A329)
PLUS Pivot Link Universal System (U1-L303T)
PLUS Pivot Link Universal System (SD-TRAY113)
PLUS Pivot Link Universal System (SD-IDPP)
PLUS Pivot Link Universal System (U1-A218S)
PLUS Pivot Link Universal System (U1-TRAY112)
PLUS Pivot Link Universal System (U1-TRAY114)
PLUS Pivot Link Universal System (U1-A214S)
PLUS Pivot Link Universal System (U1-TRAY118)
PLUS Pivot Link Universal System (U1-RACKHOOK)
PLUS Pivot Link Universal System (SD-IDC)
PLUS Pivot Link Universal System (U1-RACKVIS1)
PLUS Pivot Link Universal System (U1-RACKIS)
PLUS Pivot Link Universal System (U1-TRAY119)
PLUS Pivot Link Universal System (U1-RACKCLIP)
CURETTE (MULTIPLE BRANDS)
LUMIS
UNI-THREAD
PLUS
SPACEVISION
C3
ULIS
SpineVision Retractor
BONE (MULTIPLE BRANDS)
UNI-Thread System (L2-R611HT)
UNI-Thread System (L2-R613HT)
SpineVision surgical pliers
SpineVision Surgical Instrument Tray
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device