Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016438694

FEI Number

3016438694

Entity Name

ARCH Medical Solutions - Memphis

City/State/Country

Lexington, TN, US

Establishment Address

255 Kirby Dr, Lexington, TN 38351, 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

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CD Horizon Spinal System Smith & Nephew Globus EXCELSIUS GPS Catalyst CSR Shoulder System General Surgical Instrument Smith & Nephew HOLO Portal General Surgical Instrument General Surgical Instrument General Surgical Instrument General Surgical Instrument General Surgical Instrument Clydesdale Spinal System General Surgical Instrument General Surgical Instrument General Surgical Instrument Clydesdale Spinal System General Surgical Instrument General Surgical Instrument General Surgical Instrument Smith & Nephew General Surgical Instrument QUARTEX General Surgical Instrument Smith & Nephew General Surgical Instrument General Surgical Instrument General Surgical Instrument General Surgical Instrument CD Horizon (TM) Spinal System General Surgical Instrument General Surgical Instrument CD Horizon (TM) Spinal System General Surgical Instrument General Surgical Instrument Excelsius GPS General Surgical Instrument General Surgical Instrument General Surgical Instrument General Surgical Instrument Verte-Stack VuePoint II

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
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
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	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	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
OSH	Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	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
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
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2025-01-16
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2025-01-16
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2022-02-07
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2025-01-17
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2025-01-17
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2025-01-17
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	2025-01-15
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2025-01-15
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2025-01-16
OWI	Bone Fixation Cerclage, Sublaminar	Orthopedic	Class 2	888.3010	2025-01-16
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2025-01-16
BSK	Cuff, Tracheal Tube, Inflatable	Anesthesiology	Class 2	868.5750	2025-01-16
PDQ	Neurosurgical Nerve Locator	Ear, Nose, Throat	Class 2	874.1820	2025-01-16
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	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
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
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2025-01-16
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2019-12-17
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
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
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
PHM	Intervertebral Fusion Device With Bone Graft, Thoracic	Orthopedic	Class 2	888.3080	2025-01-16
HWT	Template	Orthopedic	Class 1	888.4800	2012-12-14
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2025-01-16
JDS	Nail, Fixation, Bone	Orthopedic	Class 2	888.3030	2020-06-05
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2020-06-05
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2020-06-05
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2020-06-05
SBF	Orthopedic Augmented Reality	Neurology	Class 2	882.4560	2023-03-27
FZY	Hammer, Surgical	General, Plastic Surgery	Class 1	878.4800	2012-12-14
HWM	Osteotome	General, Plastic Surgery	Class 1	878.4800	2012-12-14
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2025-01-16
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
PGN	Growing Rod System- Magnetic Actuation	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
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
GWJ	Stimulator, Auditory, Evoked Response	Neurology	Class 2	882.1900	2020-07-10
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	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
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2025-01-17
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2025-01-16
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2012-12-14
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2025-01-16
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	2022-02-07
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2025-01-16
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2025-01-16
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-02-07
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	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	2025-01-16
HXO	Pusher, Socket	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
FXG	Specula Accessories	General, Plastic Surgery	Class 1	878.1800	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	2025-01-15
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
KTZ	Caliper	Orthopedic	Class 1	888.4150	2012-12-14
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-02-07
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-02-07
HXB	Probe	Orthopedic	Class 1	888.4540	2012-12-14
HWA	Impactor	Orthopedic	Class 1	888.4540	2012-12-14
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	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
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2025-01-16
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2025-01-16
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2025-01-16
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2012-12-14
HXC	Wrench	Orthopedic	Class 1	888.4540	2012-12-14
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2025-01-17
NKG	Posterior Cervical Screw System	Orthopedic	Class 2	888.3075	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
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
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
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	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
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
GEA	Cannula, Surgical, General & Plastic Surgery	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
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2025-01-16
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-12-17
JDS	Nail, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-12-17
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2019-12-17
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
NBH	Accessories, Arthroscopic	Orthopedic	Class 1	888.1100	2012-12-14
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
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	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
PLR	Spinal Vertebral Body Replacement Device - Cervical	Orthopedic	Class 2	888.3060	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
PEK	Spinous Process Plate	Orthopedic	Class 2	888.3050	2025-01-16
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	2025-01-16
PHM	Intervertebral Fusion Device With Bone Graft, Thoracic	Orthopedic	Class 2	888.3080	2025-01-16
NQW	Orthosis, Spine, Plate, Laminoplasty, Metal	Orthopedic	Class 2	888.3050	2025-01-17
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
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2022-02-07
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2022-02-07
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
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
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2025-01-17
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2012-12-14
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	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
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2022-02-07
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
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2025-01-16
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	2022-02-07
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
OUR	Sacroiliac Joint Fixation	Orthopedic	Class 2	888.3040	2022-02-07
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2022-02-07
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2025-01-17
NKG	Posterior Cervical Screw System	Orthopedic	Class 2	888.3075	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
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
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2025-01-16
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	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
NQW	Orthosis, Spine, Plate, Laminoplasty, Metal	Orthopedic	Class 2	888.3050	2025-01-16
HTP	File	Orthopedic	Class 1	888.4540	2012-12-14
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	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
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2025-01-16
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2025-01-16
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2025-01-16
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2022-02-07
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
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
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2019-12-17
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2019-12-13
HTE	Elevator	General, Plastic Surgery	Class 1	878.4800	2012-12-14
HTF	Curette	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
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2025-01-16
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
FST	Light, Surgical, Fiberoptic	General, Plastic Surgery	Class 2	878.4580	2025-01-16
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
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-01-16
HXW	Bender	Orthopedic	Class 1	888.4540	2012-12-14
KDG	Chisel (Osteotome)	General, Plastic Surgery	Class 1	878.4820	2012-12-14
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Neurology	Class 2	882.4310	2022-12-12
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
HWJ	Awl	Orthopedic	Class 1	888.4540	2012-12-14
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2012-12-14
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2022-02-07
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2025-01-17
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2023-06-12
HXG	Tamp	Orthopedic	Class 1	888.4540	2012-12-14
GDG	Hook, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2012-12-14
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2026-01-29
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
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2025-01-17
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2012-12-14
GES	Blade, Scalpel	General, Plastic Surgery	Class 1	878.4800	2012-12-14
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
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
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	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
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2012-12-14
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2025-01-17
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	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	2025-01-16
NKG	Posterior Cervical Screw System	Orthopedic	Class 2	888.3075	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
3009973505	ARCH Medical Solutions - Memphis	BARTLETT, TN, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K963639	Acromed Corp.	ACROMED PEDICLE SCREW	1996-11-14
K012175	Encore Orthopedics, Inc.	PASS SPINAL SYSTEM	2001-07-31
K032604	Co-Ligne AG	GII SPINAL FIXATION SYSTEM	2004-01-20
K964304	Osteonics Corp.	OSTEONICS SPINAL SYSTEM-TOPLOADING TRANSVERSE CONNECTOR ASSEMBLY	1997-01-17
K163363	Surgtech, Inc.	SurgTech Thoracolumbosacral (TLS) Posterior Fixation System	2017-04-05

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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3016050940	Olive Branch Distribution Center	Olive Branch, MS, US
3009417901	SYNTHES GMBH	Zuchwil Solothurn, CH

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016438694. Last updated year: 2026. Please use registration number 3016438694 when referencing this establishment in official correspondence.