FDA Registration
Active
🇺🇸 United States
MACKAY MANUFACTURING, INC.
Reg #: 3003935342
·
FEI: 3003935342
·
Expires 2026
Products
40
Proprietary Names
62
Establishment Types
1
Classifications
40
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Registration Details
- Registration Name
- MACKAY MANUFACTURING, INC.
- Registration Number
- 3003935342
- FEI Number
- 3003935342
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 10011 E Montgomery Dr
- City
- Spokane Valley
- State
- WA
- ZIP
- 99206
- Country
- US
Owner / Operator
- Firm Name
- MacKay Manufacturing, Inc.
- Operator Number
- 10042071
- Address
- 10011 E. Montgomery Drive
- City
- Spokane Valley
- State
- WA
- Postal Code
- 99206
- Country
- US
- Correspondent
- Don Ludington
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bone Fixation Cerclage, Sublaminar | OWI | Class 2 | Orthopedic | No | 2025-01-22 |
| Intervertebral Fusion Device With Bone Graft, Thoracic | PHM | Class 2 | Orthopedic | No | 2025-01-22 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2025-01-22 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2025-01-22 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2025-01-22 |
| Spinal Vertebral Body Replacement Device - Cervical | PLR | Class 2 | Orthopedic | No | 2025-01-22 |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | Class 2 | General Hospital | No | 2025-01-22 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2025-01-22 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2025-01-20 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2025-01-20 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2025-01-20 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2025-01-20 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2025-01-20 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2025-01-21 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2025-01-22 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2025-01-22 |
| System, X-Ray, Fluoroscopic, Image-Intensified | JAA | Class 2 | Radiology | No | 2025-01-22 |
| Interventional Fluoroscopic X-Ray System | OWB | Class 2 | Radiology | No | 2025-01-22 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2021-04-05 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2013-01-16 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2013-01-16 |
| Neurosurgical Nerve Locator | PDQ | Class 2 | Ear, Nose, Throat | No | 2025-01-21 |
| Cuff, Tracheal Tube, Inflatable | BSK | Class 2 | Anesthesiology | No | 2025-01-21 |
| Tube, Tracheal (W/Wo Connector) | BTR | Class 2 | Anesthesiology | No | 2025-01-21 |
| Stimulator, Nerve | ETN | Class 2 | Ear, Nose, Throat | No | 2025-01-22 |
| Stimulator, Electrical, Evoked Response | GWF | Class 2 | Neurology | No | 2025-01-22 |
| Electromyograph, Diagnostic | IKN | Class 2 | Physical Medicine | No | 2025-01-22 |
| Neurological Stereotaxic Instrument | HAW | Class 2 | Neurology | No | 2025-01-22 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2021-04-05 |
| Light, Surgical, Fiberoptic | FST | Class 2 | General, Plastic Surgery | No | 2025-01-20 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2013-01-16 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2013-01-16 |
| Orthosis, Spine, Plate, Laminoplasty, Metal | NQW | Class 2 | Orthopedic | No | 2025-01-22 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2021-04-05 |
| Prosthesis, Intervertebral Disc | MJO | Class 3 | Unknown | No | 2025-01-22 |
| Bone Cement, Posterior Screw Augmentation | PML | Class 2 | Orthopedic | No | 2025-01-22 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2021-04-05 |
| Growing Rod System- Magnetic Actuation | PGN | Class 2 | Orthopedic | No | 2025-01-22 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2025-01-22 |
| Accessories, Arthroscopic | NBH | Class 1 | Orthopedic | No | 2013-01-16 |
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
Mainstay Zip Anchor System
Inter-Lock System
FREE GLIDING SLIPPED CAPITAL FEMORAL EPIPHYSIS SCREW (SCFE)
WINGMAN SCOPE HOLDER
FASSIRE-DUVAL TELESCOPIC IM SYSTEM
The Locking Pediatric Osteotomy Plate (LolliPOP) System
GAP ENDO-EXO MEDULLARY SYSTEM
FASSIER-DUVAL TELSCOPIC IM SYSTEM
HINGE PEDIATRIC PLATING SYSTEM
HIP 5.5MM CANNULA
4.6 X 200 MM CANNULA, 1 ROTATING STOPCOCK, NO DISTAL HOLES
HIP 4MM CANNULA
HIP OBTROCAR FOR 5.5MM CANNULA
CANNULA 4MM
CANNULATED PENCIL TIP OBTURATOR FOR LONG 5.8MM SCOPE SHEATH
4.6 X 200 MM CANNULA, 2 ROTATING STOPCOCKS
HIP OBTURATOR FOR 5MM CANNULA
NANOTACK FLEX OBTURATOR
NANOTACK GUIDE
NANOTACK FLEX GUIDE
CINCHLOCK OBTURATOR
NANOTACK OBTURATOR
4.6 X 200 MM CANNULA, 2 ROTATING STOPCOCKS AT 95 DEGREES
KNOT PUSHER
CINCHLOCK DRILL GUIDE
4.6 X 200 MM CANNULA, 2 FIXED STOPCOCKS AT 95 DEGREES
CAPSULE PUNCH
TRANSPORT OBTURATOR, REUSABLE
HIP 5MM CANNULA
HIP TROCAR FOR 4MM CANNULA
CANNULATED OBTURATOR FOR 4.6 X 200 MM CANNULA
CANNULA 4MM W/2 ROTATING STOPCOCKS
HIP BRIDGE, DUAL FIXED STOPCOCKS
4.6 X 200 MM CANNULA, 1 FIXED STOPCOCK
HIP BRIGE, SINGLE FIXED STOPCOCK
HIP OBTURATOR FOR 4MM CANNULA
SCREWDRIVER HANDLE
4.6 X 200 MM CANNULA, 2 FIXED STOPCOCKS
HIP 5.5MM CANNULA, WITH DISTAL HOLES
HIP TROCAR FOR 5.5MM CANNULA
OBTURATOR FOR 4.6 X 200 MM CANNULA
HIP 4MM CANNULA, WITH DISTAL HOLES
HIP 5MM CANNULA, WITH DISTAL HOLES
HIP OBTROCAR FOR 4MM CANNULA
HIP OBTURATOR FOR 5.5MM CANNULA
TROCAR FOR 4.6 X 200 MM CANNULA
HIP BRIDGE, DUAL ROTATING STOPCOCKS
HIP OBTROCAR FOR 5MM CANNULA
4.6 X 200 MM CANNULA, 1 ROTATING STOPCOCK
HIP TROCAR FOR 5MM CANNULA
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)