Evolution Spine, LLC
Dallas, TX, US
EVOLUTION SPINE, LLC appears in FDA device records in Dallas, TX. FDA records list 14 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 14 510(k) clearances for Evolution Spine, LLC between 2016 and 2026. The busiest year on record is 2024, with 3. The most recent is 2026, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2016 | 2 |
| 2017 | 1 |
| 2018 | 1 |
| 2019 | 1 |
| 2021 | 1 |
| 2022 | 1 |
| 2023 | 1 |
| 2024 | 3 |
| 2025 | 1 |
| 2026 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K262094 | E3D™-C Interbody System | OVE | Substantially Equivalent | |
| K260038 | E3D™-C Interbody System | OVE | Substantially Equivalent | |
| K250167 | Evolution Spine Navigation Instruments | OLO | Substantially Equivalent | |
| K241846 | E3D™-C Interbody System | OVE | Substantially Equivalent | |
| K240368 | E3D™-A Interbody System | OVD | Substantially Equivalent | |
| K232432 | E3D™-A Interbody System | OVD | Substantially Equivalent | |
| K223146 | EVOLUTION SPINE Interbody System | OVD | Substantially Equivalent | |
| K220275 | EMERGE Anterior Cervical Plate System | KWQ | Substantially Equivalent | |
| K212405 | EMERGE™ Anterior Cervical Plate System | KWQ | Substantially Equivalent | |
| K182478 | Whistler Modular Pedicle Screw System | NKB | Substantially Equivalent | |
| K180755 | Vail ALIF Buttress Plate System | KWQ | Substantially Equivalent | |
| K173375 | Anterior Cervical Plate System | KWQ | Substantially Equivalent | |
| K160663 | Lumbar Interbody Fusion System (ALIF, PLIF, LLIF, TPLIF) | MAX | Substantially Equivalent | |
| K160324 | Cervical Interbody Fusion System | ODP | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3012428435 | 3012428435 | EVOLUTION SPINE, LLC | 2300 N Haskell Ave, Dallas, TX 75204 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KWQAppliance, Fixation, Spinal Intervertebral Body
- ODPIntervertebral Fusion Device With Bone Graft, Cervical
- MAXIntervertebral Fusion Device With Bone Graft, Lumbar
- PHMIntervertebral Fusion Device With Bone Graft, Thoracic
- OVEIntervertebral Fusion Device With Integrated Fixation, Cervical
- OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar
- OLOOrthopedic Stereotaxic Instrument
- NKBThoracolumbosacral Pedicle Screw System
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain