SPINEVISION SAS

FDA Device Registration & Listing · Antony Hauts-de-Seine, FR · Registration 3003526896

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3003526896
FEI Number
3003526896
Entity Name
SPINEVISION SAS
City/State/Country
Antony Hauts-de-Seine, FR
Establishment Address
3 Rue De La Renaissance, Antony Hauts-de-Seine 92160, FR
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
SPINEVISION SAS (Owner Number: 9048013)
Owner / Operator Contact Address
3 rue de la Renaissance, Antony, FR-75 F-92160, FR
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K221578
PMA Number
N/A

All Registered 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 UNI-Thread System PLUS Pivot Link Universal 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 Hexanium® ACIF 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2007-11-05
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2007-11-05
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2007-11-05
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2020-10-29
HXW Bender Orthopedic Class 1 888.4540 2002-02-21
HWR Driver, Prosthesis Orthopedic Class 1 888.4540 2002-02-21
HXK Holder, Needle; Orthopedic Orthopedic Class 1 888.4540 2018-05-11
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2016-05-20
HXX Screwdriver Orthopedic Class 1 888.4540 2002-02-21
HWA Impactor Orthopedic Class 1 888.4540 2005-01-13
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-08-02
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-08-02
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-08-02
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-08-02
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2023-09-11
HWT Template Orthopedic Class 1 888.4800 2002-02-21
FZY Hammer, Surgical General, Plastic Surgery Class 1 878.4800 2005-01-13
HTO Reamer Orthopedic Class 1 888.4540 2005-01-13
HWJ Awl Orthopedic Class 1 888.4540 2002-02-21
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2012-06-20
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2012-06-20
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2012-06-20
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2012-06-20
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2012-06-20
HTJ Gauge, Depth Orthopedic Class 1 888.4300 2002-02-21
HXC Wrench Orthopedic Class 1 888.4540 2002-02-21
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-07-17
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-07-17
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-07-17
HXB Probe Orthopedic Class 1 888.4540 2002-02-21
HWK Trephine Orthopedic Class 1 888.4540 2002-02-21
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-07-17
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-07-17
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2002-02-21
HXG Tamp Orthopedic Class 1 888.4540 2018-05-11
HXZ Cutter, Wire Orthopedic Class 1 888.4540 2010-03-22
HTZ Instrument, Cutting, Orthopedic General, Plastic Surgery Class 1 878.4800 2002-02-21
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2007-11-05
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2007-11-05
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2007-11-05
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-07-17
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-07-17
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-07-17
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2007-11-05
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2007-11-05
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2007-11-05
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2007-11-05
HTW Bit, Drill Orthopedic Class 1 888.4540 2002-02-21
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2002-02-21
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2023-09-08

Official Correspondent

Quang TRAN

US Agent Details

Sylvain Chambat Email: s.chambat@clariance-spine.us Phone: (773) 8327554

Related Public Records

Same Entity

SPINEVISION SAS
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K012175 Encore Orthopedics, Inc. PASS SPINAL SYSTEM 2001-07-31
K963639 Acromed Corp. ACROMED PEDICLE SCREW 1996-11-14
K032604 Co-Ligne AG GII SPINAL FIXATION SYSTEM 2004-01-20
K964304 Osteonics Corp. OSTEONICS SPINAL SYSTEM-TOPLOADING TRANSVERSE CONNECTOR ASSEMBLY 1997-01-17
K223430 Life Spine, Inc. ProLift Micro Expandable Spacer System 2023-05-04

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0026-2011 Zimmer Inc. 2
SpeedLink 5.5 Transverse Connector Short 39.5-44mm, non-sterile, 1302-55S
Z-0027-2011 Zimmer Inc. 2
SpeedLink 5.5 Transverse Connector Medium 43-51mm, non-sterile, 1302-55M
Z-0028-2011 Zimmer Inc. 2
SpeedLink 5.5 Transverse Connector Long 50-65mm, non-sterile, 1302-55L
Z-0029-2011 Zimmer Inc. 2
SpeedLink 5.5 Transverse Connector X-Long 60-75mm, non-sterile, 1302-55XL
Z-0030-2011 Zimmer Inc. 2
SpeedLink 6.0 Transverse Connector Short 39.5-44mm, non-sterile, 1304-60S

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003526896. Last updated year: 2026. Please use registration number 3003526896 when referencing this establishment in official correspondence.
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