Data / Medical devices / United States / Boxspine, LLC
Boxspine, LLC: FDA-registered device maker in Plymouth, IN, United States, 3 510(k) clearances
Boxspine, LLC is registered with the FDA (registration 3027807601) in Plymouth, IN, United States. It lists 9 device types. The FDA files 3 510(k) clearances under its listings, the newest dated February 23, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3027807601
- Address
- 3501 Miller Dr, Plymouth, IN, United States, 46563
- Owner or operator
- BoxSPINE, LLC (10088535)
- Roles
- Complaint file establishment, Repackager or relabeler, Specification developer
- First device listed
- August 9, 2023
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Appliance, Fixation, Spinal Interlaminal | KWP | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Guide, Surgical, Instrument | FZX | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Kit, Surgical Instrument, Disposable | KDD | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Probe | HXB | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Thoracolumbosacral Pedicle Screw System | NKB | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 23, 2026 | K253169 | Duet Spinal Fixation System | NKB | Substantially Equivalent | Box Spine, LLC | accessdata.fda.gov |
| December 5, 2025 | K250764 | SpineLinc Anterior Cervical Implant System | ODP | Substantially Equivalent | Lincotek Medical | accessdata.fda.gov |
| May 12, 2020 | K192930 | Dymaxeon Spine System | NKB | Substantially Equivalent | Back 2 Basics Direct, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Kit, Surgical Instrument, Disposable
- All makers of Guide, Surgical, Instrument
- All makers of Thoracolumbosacral Pedicle Screw System
- All makers of Orthopedic Manual Surgical Instrument
- All makers of Intervertebral Fusion Device With Integrated Fixation, Cervical
- All makers of Intervertebral Fusion Device With Bone Graft, Cervical
Updated February 23, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.