GAUTHIER BIOMEDICAL, INC.

FDA Device Registration & Listing · Grafton, WI, US · Registration 2134947

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
2134947
FEI Number
3010938185
Entity Name
GAUTHIER BIOMEDICAL, INC.
City/State/Country
Grafton, WI, US
Establishment Address
2221 Washington St, Grafton, WI 53024, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
GAUTHIER BIOMEDICAL, INC. (Owner Number: 9041205)
Owner / Operator Contact Address
2221 Washington Street, Grafton, WI 53024, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
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
HXB Probe Orthopedic Class 1 888.4540 2013-01-08
HXW Bender Orthopedic Class 1 888.4540 2013-01-08
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2024-06-12
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2024-06-12
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2024-06-12
HXG Tamp Orthopedic Class 1 888.4540 2023-02-21
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2024-06-11
HWA Impactor Orthopedic Class 1 888.4540 2012-12-03
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-03-20
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-03-20
GFC Driver, Surgical, Pin General, Plastic Surgery Class 1 878.4820 2013-12-03
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2024-06-24
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-04-14
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2024-06-11
HWN Instrument, Compression Orthopedic Class 1 888.4540 2020-12-16
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2013-02-04
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2024-06-11
HTZ Instrument, Cutting, Orthopedic General, Plastic Surgery Class 1 878.4800 2023-12-15
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2025-04-10
HWR Driver, Prosthesis Orthopedic Class 1 888.4540 2013-01-08
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-01-07
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-01-07
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-01-07
LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite Orthopedic Class 2 888.3030 2024-06-11
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2024-06-11
HWT Template Orthopedic Class 1 888.4800 2011-01-11
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2013-01-08
HWB Extractor Orthopedic Class 1 888.4540 2024-06-07
HTW Bit, Drill Orthopedic Class 1 888.4540 2024-06-07
FZY Hammer, Surgical General, Plastic Surgery Class 1 878.4800 2024-06-10
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2024-06-11
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2025-01-06
JDO Device, Fixation, Proximal Femoral, Implant Orthopedic Class 2 888.3030 2025-01-06
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2024-06-12
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2024-06-12
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2024-06-12
HWJ Awl Orthopedic Class 1 888.4540 2013-01-08
HWM Osteotome General, Plastic Surgery Class 1 878.4800 2012-12-03
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2024-06-11
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2024-06-12
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2024-06-12
ETN Stimulator, Nerve Ear, Nose, Throat Class 2 874.1820 2024-11-05
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2004-05-25
HXO Pusher, Socket Orthopedic Class 1 888.4540 2024-06-10
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2024-06-11
HTR Rasp General, Plastic Surgery Class 1 878.4800 2023-02-21
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2024-06-10
HXC Wrench Orthopedic Class 1 888.4540 2013-01-08
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2024-06-11
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2024-06-12
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2024-06-12
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2024-06-12
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2024-06-12
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2024-06-12
GAD Retractor General, Plastic Surgery Class 1 878.4800 2023-02-21
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2024-12-18
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2025-01-09
OUR Sacroiliac Joint Fixation Orthopedic Class 2 888.3040 2024-06-11
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2025-01-06
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2025-01-06
JDO Device, Fixation, Proximal Femoral, Implant Orthopedic Class 2 888.3030 2025-01-06
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2017-11-06
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2026-01-22
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-05-12

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

GAUTHIER BIOMEDICAL, INC.
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
K142269 Reliance Medical Systems, LLC Reliance Cervical IBF System 2015-06-09
K122085 Omni Surgical, LP Dba Spine360 STINGRAY CERVICAL CAGE 2012-10-17
K120275 Synthes (Usa), LLC SYNTHES ACIS/VERTEBRAL SPACER CR 2012-05-25
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

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0001-2013 Synthes USA HQ, Inc. 2
MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous instrumentation of the thoracolumbar spine. The Synthes USS are non-cervial spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5).
Z-0004-2008 Abbott Spine 2
PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stablization system, Part Number 1156-50.
Z-0005-2008 Abbott Spine 2
PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stabilization system, Part Number 1156-60.
Z-0020-06 Pioneer Surgical Technology 2
Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 45 mm; Catalog number 10-575-PA-45.
Z-0021-06 Pioneer Surgical Technology 2
Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 40 mm; Catalog number 10-575-PA-40.

Similar Registrations

Registration Number Establishment Name Location
3004215117 MILLENNIUM SURGICAL CORP Schaumburg, IL, US
1421879 PHOENIX INSTRUMENTS, INC. Lisle, IL, US
3010155661 Synergy Health Sterilisation UK Ltd Thorne Doncaster, GB
3015516266 Depuy Ireland UC Co. Cork Munster, IE
1424434 ARCH Medical Solutions - Elmhurst Elmhurst, IL, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2134947. Last updated year: 2026. Please use registration number 2134947 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.