FDA Registration
Active
🇺🇸 United States
SPINEFRONTIER, INC. DBA LESspine Innovations
Reg #: 3005977257
·
FEI: 3005977257
·
Expires 2026
Products
13
Proprietary Names
28
Establishment Types
2
Classifications
13
Registration Details
- Registration Name
- SPINEFRONTIER, INC. DBA LESspine Innovations
- Registration Number
- 3005977257
- FEI Number
- 3005977257
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 200 Summit Drive, Suite 505
- City
- Burlington
- State
- MA
- ZIP
- 01803
- Country
- US
Regulatory Submissions
- 510(k) Number
- K243774
Owner / Operator
- Firm Name
- LESspine Innovations
- Operator Number
- 9094359
- Address
- 200 Summit Dr, Suite 505
- City
- Burlington
- State
- MA
- Postal Code
- 01803
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Rongeur, Manual | HAE | Class 2 | Neurology | No | 2026-02-04 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2026-02-04 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2018-08-13 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2018-08-13 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2026-01-15 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2016-07-18 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2016-07-18 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2026-01-15 |
| Spinous Process Plate | PEK | Class 2 | Orthopedic | No | 2026-01-15 |
| Sacroiliac Joint Fixation | OUR | Class 2 | Orthopedic | No | 2026-01-15 |
| System, Facet Screw Spinal Device | MRW | Class U | Unknown | No | 2026-01-15 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2026-01-15 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2008-08-18 |
Proprietary Names
ELID
Endoscopic Less Invasive Decompression
A-CIFT SoloFuse
P-LIFT
Dorado
E-LIFT
S-LIFT
T-LIFT
Arena-L
TILT
Arena-C HA
Reset
Return
PedFuse
Respond
Remind
MISquito
Arena-C
Inset (KWQ)
SacroFuse (OUR)
Sacrix (OUR)
Vega (PEK)
Invue Max (KWQ)
Invue (KWQ)
FacetFuse (MRW)
Inspan Slim (PEK)
Inspan (PEK)
VertiFix
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device