FDA Registration
Active
🇺🇸 United States
LIFE SPINE
Reg #: 3004499989
·
FEI: 3004499989
·
Expires 2026
Products
22
Proprietary Names
75
Establishment Types
1
Classifications
22
Registration Details
- Registration Name
- LIFE SPINE
- Registration Number
- 3004499989
- FEI Number
- 3004499989
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 13951 Quality Dr
- City
- Huntley
- State
- IL
- ZIP
- 60142
- Country
- US
Regulatory Submissions
- 510(k) Number
- K180749
Owner / Operator
- Firm Name
- LIFE SPINE
- Operator Number
- 9061495
- Address
- 13951 S Quality Drive
- City
- Huntley
- State
- IL
- Postal Code
- 60142
- Country
- US
- Correspondent
- Angela Batker
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2019-01-16 |
| Sacroiliac Joint Fixation | OUR | Class 2 | Orthopedic | No | 2019-01-16 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2020-02-13 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2020-02-13 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2013-04-24 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2013-04-24 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2013-04-24 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2026-06-15 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2019-01-14 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2018-05-07 |
| Posterior Cervical Screw System | NKG | Class 2 | Orthopedic | No | 2018-05-07 |
| Curette, Surgical, General Use | FZS | Class 1 | General, Plastic Surgery | No | 2017-03-22 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2013-04-24 |
| Orthosis, Spine, Plate, Laminoplasty, Metal | NQW | Class 2 | Orthopedic | No | 2019-11-01 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2018-03-08 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2010-11-05 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2020-08-14 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2013-12-03 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2018-09-12 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2016-05-17 |
| Prosthesis, Toe, Hemi-, Phalangeal | KWD | Class 2 | Orthopedic | No | 2022-06-22 |
| Prosthesis, Hip, Cement Restrictor | JDK | Class 2 | General, Plastic Surgery | No | 2006-08-01 |
Proprietary Names
SImpact
Dyna-Link Ti
Nautilus
Pilot
Simpact GX
ProLift Lateral HELO Fixated
Sentry
Solstice
ProLift
General Instrument
Pro-Link
Resolute
Steerable Plateau Ti
ProLift Wedge
Plateau
TruLift
Longbow Ti
Simpact
ARx Modular
Solstice OCT
Hinged Laminoplasty
TruLift Lateral Modular
Gruve +
Tarsa-Link Wedge
ProLink Ti
Nautilus & Solstice
Foot and Ankle Plate
Hammertoe
MIS ACP
Rogue +
ProLift Micro
ARX SAI
ProLift Pivot
Lynx
Rogue
Cannulated Screw
Lynx 2
Centerline Modular
ProLift Lateral
ALIF Buttress Plate
ProLift Lateral and ProLift Lateral Fixated
Nautilus & Avatar
Solstice CCI
Iris
Graft Deilvery Device - Nordson
Plateau A & X Ti
Tarsa-Link
Laminoplasty
Tibow Ti
Arthoereisis
ARx SAI
Aileron
Retractor
Pro-Link Ti
Ghost
ARx
Stand alone Spacer
ARX
Saturn
Trulift Micro
Arx Illiac
Pro-Link Wedge
ProLift Lateral Fixated
Hemi-Toe
Presidio
VersaLift
Plateau-C
Cement Restrictor
Gx Navigation
LongBow Ti
Plateau-Lo
Dyna-Link Elite
2 hole plate
Plateau TI
Pro-Link Barb
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility