Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003935342

FEI Number

3003935342

Entity Name

MACKAY MANUFACTURING, INC.

City/State/Country

Spokane Valley, WA, US

Establishment Address

10011 E Montgomery Dr, Spokane Valley, WA 99206, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

MacKay Manufacturing, Inc. (Owner Number: 10042071)

Owner / Operator Contact Address

10011 E. Montgomery Drive, Spokane Valley, WA 99206, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

The Simple Locking IntraMedullary (SLIM) System MONOPOLAR ELECTROSURGICAL PROBE, J-TIP, 33CM MONOPOLAR ELECTROSURGICAL PROBE, L-TIP, 33CM MONOPOLAR ELECTROSURGICAL PROBE, SPATULA TIP, 45CM MONOPOLAR ELECTROSURGICAL PROBE, L-TIP, 45CM MONOPOLAR ELECTROSURGICAL PROBE, SPATULA TIP, 33CM Cross-Screw System Bioabsorable Wedge Interference Screw System Biosteon Wedge Interference Screw System The Simple Locking Intramedullary (Slim) System Y3 Proximal Femoral Plate System Universal ACL Instrumentation Cross-Screw System Mainstay Zip Anchor System Universal ACL Instrumentation Biosteon Wedge Interference Screw System Bioabsorable Wedge Interference Screw System Inter-Lock System FREE GLIDING SLIPPED CAPITAL FEMORAL EPIPHYSIS SCREW (SCFE) WINGMAN SCOPE HOLDER FASSIRE-DUVAL TELESCOPIC IM SYSTEM

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OWI	Bone Fixation Cerclage, Sublaminar	Orthopedic	Class 2	888.3010	2025-01-22
PHM	Intervertebral Fusion Device With Bone Graft, Thoracic	Orthopedic	Class 2	888.3080	2025-01-22
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2025-01-22
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2025-01-22
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2025-01-22
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2025-01-22
PLR	Spinal Vertebral Body Replacement Device - Cervical	Orthopedic	Class 2	888.3060	2025-01-22
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2025-01-22
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2025-01-22
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2025-01-20
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2025-01-20
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2025-01-20
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2025-01-20
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2025-01-20
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2025-01-21
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2025-01-21
OSH	Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	Orthopedic	Class 2	888.3070	2025-01-22
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2025-01-22
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2025-01-22
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2025-01-22
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2025-01-22
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2025-01-22
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2025-01-21
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2025-01-21
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2025-01-21
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2025-01-21
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2025-01-21
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2025-01-22
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2025-01-22
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2025-01-22
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2025-01-22
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2025-01-22
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2025-01-21
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2021-04-05
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2025-01-21
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2025-01-21
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2025-01-22
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2013-01-16
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2013-01-16
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2025-01-22
OSH	Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	Orthopedic	Class 2	888.3070	2025-01-22
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2025-01-22
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2025-01-22
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2025-01-22
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2025-01-22
PDQ	Neurosurgical Nerve Locator	Ear, Nose, Throat	Class 2	874.1820	2025-01-21
BSK	Cuff, Tracheal Tube, Inflatable	Anesthesiology	Class 2	868.5750	2025-01-21
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2025-01-21
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2025-01-22
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2025-01-22
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2025-01-22
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2025-01-22
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2025-01-22
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2025-01-22
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2025-01-22
PDQ	Neurosurgical Nerve Locator	Ear, Nose, Throat	Class 2	874.1820	2025-01-22
IKN	Electromyograph, Diagnostic	Physical Medicine	Class 2	890.1375	2025-01-22
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2025-01-22
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2025-01-22
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2025-01-22
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2021-04-05
OSH	Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	Orthopedic	Class 2	888.3070	2025-01-22
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2025-01-22
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2025-01-22
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2025-01-22
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2025-01-22
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2025-01-22
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2025-01-21
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-04-05
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2025-01-22
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2025-01-22
PDQ	Neurosurgical Nerve Locator	Ear, Nose, Throat	Class 2	874.1820	2025-01-22
IKN	Electromyograph, Diagnostic	Physical Medicine	Class 2	890.1375	2025-01-22
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2025-01-22
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2025-01-22
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2025-01-21
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2025-01-21
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2025-01-21
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2025-01-21
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2025-01-21
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2025-01-21
PLR	Spinal Vertebral Body Replacement Device - Cervical	Orthopedic	Class 2	888.3060	2025-01-22
FST	Light, Surgical, Fiberoptic	General, Plastic Surgery	Class 2	878.4580	2025-01-20
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2025-01-22
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2025-01-22
PHM	Intervertebral Fusion Device With Bone Graft, Thoracic	Orthopedic	Class 2	888.3080	2025-01-22
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2025-01-22
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2025-01-22
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2025-01-22
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2025-01-20
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2025-01-21
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2025-01-22
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2025-01-22
PHM	Intervertebral Fusion Device With Bone Graft, Thoracic	Orthopedic	Class 2	888.3080	2025-01-22
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2013-01-16
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2013-01-16
NQW	Orthosis, Spine, Plate, Laminoplasty, Metal	Orthopedic	Class 2	888.3050	2025-01-22
PHM	Intervertebral Fusion Device With Bone Graft, Thoracic	Orthopedic	Class 2	888.3080	2025-01-22
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2025-01-22
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-04-05
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2013-01-16
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2025-01-22
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2025-01-22
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2025-01-22
MJO	Prosthesis, Intervertebral Disc	Unknown	Class 3	N/A	2025-01-22
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2021-04-05
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2025-01-20
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2025-01-21
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2025-01-22
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2025-01-22
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2025-01-22
PML	Bone Cement, Posterior Screw Augmentation	Orthopedic	Class 2	888.3027	2025-01-22
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2025-01-22
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2025-01-22
PDQ	Neurosurgical Nerve Locator	Ear, Nose, Throat	Class 2	874.1820	2025-01-22
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2025-01-22
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2025-01-22
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2025-01-22
IKN	Electromyograph, Diagnostic	Physical Medicine	Class 2	890.1375	2025-01-22
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2025-01-22
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2025-01-21
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2025-01-21
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2025-01-21
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2025-01-21
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2025-01-21
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2025-01-21
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2025-01-22
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2025-01-21
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2025-01-21
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2025-01-21
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2025-01-21
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2025-01-21
PHM	Intervertebral Fusion Device With Bone Graft, Thoracic	Orthopedic	Class 2	888.3080	2025-01-22
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2025-01-22
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2025-01-22
IKN	Electromyograph, Diagnostic	Physical Medicine	Class 2	890.1375	2025-01-22
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2025-01-22
PDQ	Neurosurgical Nerve Locator	Ear, Nose, Throat	Class 2	874.1820	2025-01-22
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2025-01-22
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2025-01-22
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2025-01-22
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2025-01-22
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2025-01-22
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2025-01-20
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2025-01-22
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2025-01-21
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2025-01-21
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2025-01-21
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2025-01-21
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2025-01-21

Official Correspondent

Don Ludington

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MacKay Manufacturing, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Related Recall Records

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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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003935342. Last updated year: 2026. Please use registration number 3003935342 when referencing this establishment in official correspondence.