Data / Medical devices / United States / Evolution Spine, LLC
Evolution Spine, LLC: FDA-registered device maker in Dallas, TX, United States, 14 510(k) clearances
Evolution Spine, LLC is registered with the FDA (registration 3012428435) in Dallas, TX, United States. It lists 8 device types. The FDA files 14 510(k) clearances under its listings, the newest dated February 4, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012428435
- Address
- 2300 N Haskell Ave, Dallas, TX, United States, 75204
- Owner or operator
- Evolution Spine, LLC (10051848)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- May 10, 2016
- Registered through
- 2026
- Brand names listed
- E3D-A Interbody System, E3D-C Interbody System, E3D-A Interbody System, EMERGE Anterior Cervical Plate System, Evolution Spine Cervical Interbody Fusion System, Evolution Spine Interbody System, Evolution Spine Navigation Instruments, Skye Cervical Plate System and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Intervertebral Fusion Device With Bone Graft, Thoracic | PHM | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Orthopedic Stereotaxic Instrument | OLO | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Thoracolumbosacral Pedicle Screw System | NKB | 2 | Complaint file establishment, Manufacturer, 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 4, 2026 | K260038 | E3D-C Interbody System | OVE | Substantially Equivalent | Evolution Spine | accessdata.fda.gov |
| August 18, 2025 | K250167 | Evolution Spine Navigation Instruments | OLO | Substantially Equivalent | Evolution Spine | accessdata.fda.gov |
| August 12, 2024 | K241846 | E3D-C Interbody System | OVE | Substantially Equivalent | Evolution Spine | accessdata.fda.gov |
| May 15, 2024 | K240368 | E3D-A Interbody System | OVD | Substantially Equivalent | Evolution Spine | accessdata.fda.gov |
| January 30, 2024 | K232432 | E3D-A Interbody System | OVD | Substantially Equivalent | Evolution Spine | accessdata.fda.gov |
| February 7, 2023 | K223146 | EVOLUTION SPINE Interbody System | OVD | Substantially Equivalent | Evolution Spine | accessdata.fda.gov |
| March 18, 2022 | K220275 | EMERGE Anterior Cervical Plate System | KWQ | Substantially Equivalent | Evolution Spine | accessdata.fda.gov |
| September 30, 2021 | K212405 | EMERGE Anterior Cervical Plate System | KWQ | Substantially Equivalent | Evolution Spine | accessdata.fda.gov |
| January 15, 2019 | K182478 | Whistler Modular Pedicle Screw System | NKB | Substantially Equivalent | Evolution Spine, LLC | accessdata.fda.gov |
| July 27, 2018 | K181554 | Stowe Pedicle Screw System | NKB | Substantially Equivalent | Black Box Medical | accessdata.fda.gov |
| July 6, 2018 | K180755 | Vail ALIF Buttress Plate System | KWQ | Substantially Equivalent | Evolution Spine, LLC | accessdata.fda.gov |
| December 21, 2017 | K173375 | Anterior Cervical Plate System | KWQ | Substantially Equivalent | Evolution Spine, LLC | accessdata.fda.gov |
| November 16, 2016 | K160663 | Lumbar Interbody Fusion System (ALIF, PLIF, LLIF, TPLIF) | MAX | Substantially Equivalent | Evolution Spine, LLC | accessdata.fda.gov |
| May 5, 2016 | K160324 | Cervical Interbody Fusion System | ODP | Substantially Equivalent | Evolution Spine, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Intervertebral Fusion Device With Bone Graft, Lumbar
- All makers of Intervertebral Fusion Device With Integrated Fixation, Cervical
- All makers of Intervertebral Fusion Device With Bone Graft, Cervical
- All makers of Appliance, Fixation, Spinal Intervertebral Body
- All makers of Orthopedic Stereotaxic Instrument
- All makers of Thoracolumbosacral Pedicle Screw System
Updated February 4, 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.