LDR MEDICAL

FDA Device Registration & Listing · Sainte-Savine Aube, FR · Registration 3004788213

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
3004788213
FEI Number
3004788213
Entity Name
LDR MEDICAL
City/State/Country
Sainte-Savine Aube, FR
Establishment Address
Parc dentreprises du Grande Troyes, Quartier Europe de lOuest, 5 rue de Berlin, Sainte-Savine Aube 10300, FR
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Highridge Medical, LLC (Owner Number: 9068198)
Owner / Operator Contact Address
10225 Westmoor Drive, Westminster, CO 80021, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K151934
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2008-12-10
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2016-09-19
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2016-09-19
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2016-09-19
HWT Template Orthopedic Class 1 888.4800 2014-02-06
GFI Osteotome, Manual General, Plastic Surgery Class 1 878.4800 2018-02-22
MJO Prosthesis, Intervertebral Disc Unknown Class 3 N/A 2017-10-26
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2007-12-12
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2012-04-30
FZS Curette, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2012-04-30
HTX Rongeur Orthopedic Class 1 888.4540 2012-04-30
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2010-12-21
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2010-12-21
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2010-12-21
HXB Probe Orthopedic Class 1 888.4540 2012-04-30
LRP Tray, Surgical General, Plastic Surgery Class 1 878.4800 2012-04-30
QLQ Manual Instruments Designed For Use With Total Disc Replacement Devices Orthopedic Class 2 888.4515 2021-04-07
HXX Screwdriver Orthopedic Class 1 888.4540 2012-04-30
HWA Impactor Orthopedic Class 1 888.4540 2012-04-30
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2012-04-03
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2012-04-03
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2007-12-12
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2009-06-24
HXR Spatula, Orthopedic General, Plastic Surgery Class 1 878.4800 2012-04-30
KDG Chisel (Osteotome) General, Plastic Surgery Class 1 878.4820 2012-04-30
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2008-12-10
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2007-12-12
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2007-12-12
GEN Forceps, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2012-04-30
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2020-03-20
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2012-08-01
HXC Wrench Orthopedic Class 1 888.4540 2012-04-30
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-02-20
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-02-20
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-02-20
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-02-20
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2007-12-12
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2007-12-12
HXW Bender Orthopedic Class 1 888.4540 2012-04-26
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2007-12-12
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2007-12-12
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2007-12-12
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2007-12-12
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2007-12-12
HWJ Awl Orthopedic Class 1 888.4540 2012-04-30
HWX Tap, Bone Orthopedic Class 1 888.4540 2012-04-30
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2012-09-14
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2012-09-14
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2012-09-14
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2012-09-14
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2012-09-14
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2012-09-14
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2012-09-14
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2012-09-14
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2012-09-14
HTR Rasp General, Plastic Surgery Class 1 878.4800 2012-04-30
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2009-12-23
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2009-12-23
HTJ Gauge, Depth Orthopedic Class 1 888.4300 2011-12-31
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2007-12-12
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2005-02-18
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2010-02-11
MRW System, Facet Screw Spinal Device Unknown Class U N/A 2016-01-26
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2016-11-01
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2008-12-10
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2008-12-10
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2008-12-10
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2008-12-10
HTW Bit, Drill Orthopedic Class 1 888.4540 2012-04-30
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2017-05-16
PEK Spinous Process Plate Orthopedic Class 2 888.3050 2014-05-08
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2007-12-12
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2007-12-12
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2010-12-21
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2010-12-21
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2010-12-21
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2009-06-24
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2016-01-26

Official Correspondent

Alex Pawlowski

US Agent Details

Elizabeth Ebmeier Business: Highridge Medical Email: beth.ebmeier@highridgemedical.com Phone: (914) 2919211

Related Public Records

Same Entity

Highridge Medical, LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3016050940 Olive Branch Distribution Center Olive Branch, MS, US
3012447612 Highridge Medical, LLC Westminster, CO, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K041888 Signus Medizintechnik GmbH CURVED PEEK TETRIS SPINAL IMPLANT 2004-08-10
K211892 Arftx Medical, LLC ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages) 2022-10-06
K070082 Vertebration,Inc XY COR SPINAL IMPLANT FOR MINIMAL INVASIVE SPINAL SURGERY 2007-04-20
K051027 Surgicraft , Ltd. STALIF TT 2005-06-29
K223430 Life Spine, Inc. ProLift Micro Expandable Spacer System 2023-05-04

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0027-2016 Zimmer, Inc. 1
Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
Z-0034-2012 X Spine Systems Inc 1
Axle Interspinous Fusion System Torque Driver Handle, Model #: X060-0323, Lot # 525941, S/Ns 001-017, Lot # 525942, S/Ns 001-050, Mfr. By: Bradshaw Medical Inc., Kenosha, WI 53144 The Axle Torque Driver Handle is used to lock the set screw into the locking plate.
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004788213. Last updated year: 2026. Please use registration number 3004788213 when referencing this establishment in official correspondence.
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