FDA Registration
Active
🇺🇸 United States
SPINECRAFT LLC
Reg #: 3004717358
·
FEI: 3004717358
·
Expires 2026
Products
12
Proprietary Names
20
Establishment Types
2
Classifications
12
Registration Details
- Registration Name
- SPINECRAFT LLC
- Registration Number
- 3004717358
- FEI Number
- 3004717358
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 777 Oakmont Ln Suite 200
- City
- Westmont
- State
- IL
- ZIP
- 60559
- Country
- US
Regulatory Submissions
- 510(k) Number
- K181350
Owner / Operator
- Firm Name
- SPINECRAFT LLC
- Operator Number
- 9065601
- Address
- 777 Oakmont Lane, Suite 200
- City
- Westmont
- State
- IL
- Postal Code
- 60559
- Country
- US
- Correspondent
- AMI - AKALLAL-ASAAD
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2018-09-19 |
| Posterior Cervical Screw System | NKG | Class 2 | Orthopedic | No | 2018-09-19 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2011-06-09 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2013-12-30 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2013-12-30 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2013-12-30 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2026-05-12 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2026-05-12 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2026-05-12 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2015-08-03 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2023-12-06 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2016-12-27 |
Proprietary Names
ASTRA-OCT Spine System
ALLTUM Anterior Cervical Plate System
ALTUM Anterior Cervical Plate System
APEX Spine System
APEX Spine System 5.5mm Ti Rod
ORIO-3D Cage System
ORIO I/F CAGE SYSTEM
ASTRA Spine System
ORIO-Ti Intervertebral Body Fusion Cage System
APEX Spine System w/CoCr Rods
VELOX Anterior Cervical Plate System
ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments System
ORIO Cage System Instruments
ASTRA Spine System Instruments
VELOX Anterior Cervical Plate Instruments
APEX Spine System Instruments
ALTUM Anterior Cervical Plate Instruments
ANTERIS Thoracolumbar Plate System
APEX-SPINE SYSTEM
APEX SPINE SYSTEM
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device