FDA Registration
Active
🇺🇸 United States
BOXSPINE, LLC
Reg #: 3027807601
·
FEI: 3027807601
·
Expires 2026
Products
9
Proprietary Names
0
Establishment Types
3
Classifications
9
Registration Details
- Registration Name
- BOXSPINE, LLC
- Registration Number
- 3027807601
- FEI Number
- 3027807601
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 3501 Miller Dr
- City
- Plymouth
- State
- IN
- ZIP
- 46563
- Country
- US
Regulatory Submissions
- 510(k) Number
- K192930
Owner / Operator
- Firm Name
- BoxSPINE, LLC
- Operator Number
- 10088535
- Address
- 3501 Miller Dr
- City
- Plymouth
- State
- IN
- Postal Code
- 46563
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Kit, Surgical Instrument, Disposable | KDD | Class 1 | General, Plastic Surgery | No | 2026-04-02 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2025-04-04 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2025-04-04 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2025-01-17 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2026-01-15 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2026-01-15 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2026-01-15 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2025-01-10 |
| Probe | HXB | Class 1 | Orthopedic | No | 2023-08-09 |
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device