ARCH Medical Solutions - Memphis

FDA Device Registration & Listing · BARTLETT, TN, US · Registration 3009973505

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
3009973505
FEI Number
3009973505
Entity Name
ARCH Medical Solutions - Memphis
City/State/Country
BARTLETT, TN, US
Establishment Address
7580 BARTLETT CORPORATE DR, BARTLETT, TN 38133, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Arch Medical Solutions (Owner Number: 10042635)
Owner / Operator Contact Address
7580 Bartlett Corporate Dr., Bartlett, TN 38133, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

General Surgical Instrument General Surgical Instrument Globus EXCELSIUS GPS CD Horizon (TM) Spinal System General Surgical Instrument General Surgical Instrument Perimeter Interbody Fusion Device Smith & Nephew General Surgical Instrument CREO Threaded Stabilization System General Surgical Instrument QUARTEX Smith & Nephew General Surgical Instrument Excelsius GPS General Surgical Instrument CD Horizon (TM) Spinal System General Surgical Instrument General Surgical Instrument General Surgical Instrument Clydesdale Spinal System General Surgical Instrument General Surgical Instrument General Surgical Instrument General Surgical Instrument General Surgical Instrument General Surgical Instrument CD Horizon Spinal System Catalyst CSR Shoulder System General Surgical Instrument General Surgical Instrument Smith & Nephew General Surgical Instrument General Surgical Instrument Smith & Nephew Clydesdale Spinal System General Surgical Instrument General Surgical Instrument

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2022-02-07
HTE Elevator General, Plastic Surgery Class 1 878.4800 2012-12-14
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2025-01-17
PLR Spinal Vertebral Body Replacement Device - Cervical Orthopedic Class 2 888.3060 2025-01-17
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-01-16
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-01-16
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2025-01-16
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2025-01-16
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-01-16
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2025-01-16
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-01-16
HTP File Orthopedic Class 1 888.4540 2012-12-14
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-01-16
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2019-12-17
HBE Drills, Burrs, Trephines & Accessories (Simple, Powered) Neurology Class 2 882.4310 2022-12-12
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-01-16
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2025-01-16
PHM Intervertebral Fusion Device With Bone Graft, Thoracic Orthopedic Class 2 888.3080 2025-01-16
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-01-16
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-01-16
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-01-16
HTO Reamer Orthopedic Class 1 888.4540 2012-12-14
HXG Tamp Orthopedic Class 1 888.4540 2012-12-14
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2012-12-14
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2020-06-05
JDO Device, Fixation, Proximal Femoral, Implant Orthopedic Class 2 888.3030 2020-06-05
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2020-06-05
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2020-06-05
FXG Specula Accessories General, Plastic Surgery Class 1 878.1800 2012-12-14
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-01-16
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2022-02-07
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2022-02-07
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2022-02-07
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2022-02-07
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2025-01-16
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2022-02-07
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2022-02-07
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2022-02-07
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2022-02-07
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2022-02-07
GES Blade, Scalpel General, Plastic Surgery Class 1 878.4800 2012-12-14
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2022-02-07
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2022-02-07
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2022-02-07
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2025-01-17
PHM Intervertebral Fusion Device With Bone Graft, Thoracic Orthopedic Class 2 888.3080 2025-01-17
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-01-17
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2025-01-17
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-01-16
PHM Intervertebral Fusion Device With Bone Graft, Thoracic Orthopedic Class 2 888.3080 2025-01-16
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-01-16
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2025-01-16
IKN Electromyograph, Diagnostic Physical Medicine Class 2 890.1375 2025-01-16
ETN Stimulator, Nerve Ear, Nose, Throat Class 2 874.1820 2025-01-16
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2025-01-16
PDQ Neurosurgical Nerve Locator Ear, Nose, Throat Class 2 874.1820 2025-01-16
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2025-01-16
GWF Stimulator, Electrical, Evoked Response Neurology Class 2 882.1870 2025-01-16
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2025-01-16
GWF Stimulator, Electrical, Evoked Response Neurology Class 2 882.1870 2025-01-16
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2025-01-16
ETN Stimulator, Nerve Ear, Nose, Throat Class 2 874.1820 2025-01-16
PDQ Neurosurgical Nerve Locator Ear, Nose, Throat Class 2 874.1820 2025-01-16
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-01-16
IKN Electromyograph, Diagnostic Physical Medicine Class 2 890.1375 2025-01-16
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2025-01-16
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2025-01-17
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-01-17
HRX Arthroscope Orthopedic Class 2 888.1100 2019-12-13
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2020-06-05
HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3520 2020-06-05
NPJ Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2020-06-05
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2020-06-05
KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3510 2020-06-05
KRQ Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3550 2020-06-05
HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3530 2020-06-05
KRR Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3540 2020-06-05
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-01-17
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2025-01-16
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2022-02-07
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2025-01-17
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2022-02-07
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-01-16
PHM Intervertebral Fusion Device With Bone Graft, Thoracic Orthopedic Class 2 888.3080 2025-01-16
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-01-16
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-01-16
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-01-16
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2025-01-16
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2025-01-16
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-01-16
PHM Intervertebral Fusion Device With Bone Graft, Thoracic Orthopedic Class 2 888.3080 2025-01-16
GAD Retractor General, Plastic Surgery Class 1 878.4800 2012-12-14
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2026-01-29
OWI Bone Fixation Cerclage, Sublaminar Orthopedic Class 2 888.3010 2025-01-16
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2025-01-16
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-01-16
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2025-01-16
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-01-16
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-01-16
IKN Electromyograph, Diagnostic Physical Medicine Class 2 890.1375 2025-01-17
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2025-01-17
GWF Stimulator, Electrical, Evoked Response Neurology Class 2 882.1870 2025-01-17
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2025-01-17
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-01-17
ETN Stimulator, Nerve Ear, Nose, Throat Class 2 874.1820 2025-01-17
PDQ Neurosurgical Nerve Locator Ear, Nose, Throat Class 2 874.1820 2025-01-17
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2025-01-17
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2025-01-17
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2022-02-07
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2022-02-07
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2019-12-17
MJO Prosthesis, Intervertebral Disc Unknown Class 3 N/A 2025-01-17
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-01-16
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-01-16
HTW Bit, Drill Orthopedic Class 1 888.4540 2012-12-14
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-01-16
PHM Intervertebral Fusion Device With Bone Graft, Thoracic Orthopedic Class 2 888.3080 2025-01-16
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2023-06-12
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-01-16
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2025-01-16
HWX Tap, Bone Orthopedic Class 1 888.4540 2012-12-14
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-01-16
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2012-12-14
PLR Spinal Vertebral Body Replacement Device - Cervical Orthopedic Class 2 888.3060 2025-01-15
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2025-01-15
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-01-16
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2025-01-16
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2025-01-16
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-01-16
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-01-16
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-01-16
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2025-01-16
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2022-02-07
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2022-02-07
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2022-02-07
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2022-02-07
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2022-02-07
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-02-07
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2019-12-17
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2025-01-16
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2025-01-16
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2025-01-16
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2025-01-16
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-01-17
KDG Chisel (Osteotome) General, Plastic Surgery Class 1 878.4820 2012-12-14
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-01-16
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2012-12-14
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2025-01-16
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-01-17
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-01-17
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-01-17
HXO Pusher, Socket Orthopedic Class 1 888.4540 2012-12-14
ETN Stimulator, Nerve Ear, Nose, Throat Class 2 874.1820 2025-01-16
HTQ Broach Orthopedic Class 1 888.4540 2012-12-14
HTF Curette General, Plastic Surgery Class 1 878.4800 2012-12-14
HWT Template Orthopedic Class 1 888.4800 2012-12-14
HRX Arthroscope Orthopedic Class 2 888.1100 2022-02-07
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2025-01-16
PGN Growing Rod System- Magnetic Actuation Orthopedic Class 2 888.3070 2025-01-16
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2025-01-17
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2025-01-17
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-01-16
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2025-01-16
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-01-16
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-01-16
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2025-01-16
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2022-02-07
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2022-02-07
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2022-02-07
HTD Forceps General, Plastic Surgery Class 1 878.4800 2012-12-14
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2022-02-07
GWJ Stimulator, Auditory, Evoked Response Neurology Class 2 882.1900 2020-07-10
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-01-16
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-01-15
NQW Orthosis, Spine, Plate, Laminoplasty, Metal Orthopedic Class 2 888.3050 2025-01-16
GDG Hook, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2012-12-14
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2025-01-16
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-01-16
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2025-01-16
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2025-01-16
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-01-16
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-01-16
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2025-01-16
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2025-01-16
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2025-01-16
PML Bone Cement, Posterior Screw Augmentation Orthopedic Class 2 888.3027 2025-01-16
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-01-16
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-01-16
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2025-01-16
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-01-16
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-01-16
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2025-01-16
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-01-15
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2012-12-14
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2012-12-14
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2012-12-14
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2012-12-14
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2012-12-14
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2012-12-14
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2017-12-01
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2017-12-01
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2025-01-16
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2025-01-17
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-01-17
HWM Osteotome General, Plastic Surgery Class 1 878.4800 2012-12-14
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2019-12-17
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2019-12-17
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2019-12-17
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2019-12-17
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2019-12-17
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2019-12-17
PDQ Neurosurgical Nerve Locator Ear, Nose, Throat Class 2 874.1820 2025-01-16
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-01-16
IKN Electromyograph, Diagnostic Physical Medicine Class 2 890.1375 2025-01-16
GWF Stimulator, Electrical, Evoked Response Neurology Class 2 882.1870 2025-01-16
ETN Stimulator, Nerve Ear, Nose, Throat Class 2 874.1820 2025-01-16
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2025-01-16
HWJ Awl Orthopedic Class 1 888.4540 2012-12-14
JDW Pin, Fixation, Threaded Orthopedic Class 2 888.3040 2020-06-05
PDQ Neurosurgical Nerve Locator Ear, Nose, Throat Class 2 874.1820 2025-01-16
IKN Electromyograph, Diagnostic Physical Medicine Class 2 890.1375 2025-01-16
GWF Stimulator, Electrical, Evoked Response Neurology Class 2 882.1870 2025-01-16
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2025-01-16
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-01-16
ETN Stimulator, Nerve Ear, Nose, Throat Class 2 874.1820 2025-01-16
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2022-02-07
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2022-02-07
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2025-01-16
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-02-07
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2022-02-07
PHM Intervertebral Fusion Device With Bone Graft, Thoracic Orthopedic Class 2 888.3080 2025-01-17
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2025-01-17
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-01-17
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2012-12-14
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2022-02-07
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2025-01-15
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-01-15
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2025-01-17
HXX Screwdriver Orthopedic Class 1 888.4540 2012-12-14
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2025-01-17
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2025-01-17
JDS Nail, Fixation, Bone Orthopedic Class 2 888.3030 2025-01-17
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-01-16
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2022-02-07
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-01-16
PHM Intervertebral Fusion Device With Bone Graft, Thoracic Orthopedic Class 2 888.3080 2025-01-16
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2020-06-05
JDJ Mesh, Surgical, Acetabular, Hip, Prosthesis General, Plastic Surgery Class 2 878.3300 2020-06-05
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2020-06-05
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2020-06-05
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2020-06-05
LZY Prosthesis, Hip, Hemi-, Femoral, Metal Ball Orthopedic Class 2 888.3360 2020-06-05
JDQ Cerclage, Fixation Orthopedic Class 2 888.3010 2020-06-05
LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3360 2020-06-05
JDG Prosthesis, Hip, Femoral Component, Cemented, Metal Orthopedic Class 2 888.3360 2020-06-05
KWL Prosthesis, Hip, Hemi-, Femoral, Metal Orthopedic Class 2 888.3360 2020-06-05
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2020-06-05
KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Orthopedic Class 2 888.3310 2020-06-05
MBL Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous Orthopedic Class 2 888.3358 2020-06-05
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2022-02-07
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2025-01-16
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2012-12-14
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-01-16
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-01-16
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2025-01-16
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2025-01-16
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-01-16
GEA Cannula, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2012-12-14
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2025-01-16
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-01-16
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2025-01-16
FZY Hammer, Surgical General, Plastic Surgery Class 1 878.4800 2012-12-14
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2025-01-16
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-01-16

Official Correspondent

Garry Smith

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

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

Other Registrations for Same Entity

Registration Number Establishment Name Location
3016438694 ARCH Medical Solutions - Memphis Lexington, TN, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K223430 Life Spine, Inc. ProLift Micro Expandable Spacer System 2023-05-04
K102293 Globus Medical, Inc. CALIBER SPACER 2011-01-05
K193541 Nu Vasive, Incorporated NuVasive Cohere Thoracolumbar Interbody System 2020-03-30
K080401 Advanced Medical Technologies AG SHELL CAGE, WAVE CAGE, LOOP CAGE 2008-05-09
K200084 Zavation Medical Products, LLC Zavation IBF System 2020-10-19

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0036-2013 Medtronic Sofamor Danek USA Inc 2
ATLANTIS(R) Anterior Cervical Plate System VARIABLE ANGLE SCREW MODULE, REF 176-503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0037-2013 Medtronic Sofamor Danek USA Inc 2
ATLANTIS(R) Anterior Cervical Plate System FIXED ANGLE SCREW MODULE, REF 176-504, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0038-2013 Medtronic Sofamor Danek USA Inc 2
PREMIER(R) Anterior Cervical Plate System SCREW BLOCK, REF 1860503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0040-05 Zimmer Spine, Inc. 2
ATO Drill Guide Kit (All Through One Drill Guides Set), model number 07.00860.001, product is packaged in trays.
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).

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009973505. Last updated year: 2026. Please use registration number 3009973505 when referencing this establishment in official correspondence.
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