Eminent Spine
Leander, TX, US
Eminent Spine appears in FDA device records in Leander, TX. FDA records list 15 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 15
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 15 510(k) clearances for Eminent Spine between 2009 and 2025. The busiest year on record is 2009, with 2. The most recent is 2025, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2009 | 2 |
| 2010 | 1 |
| 2011 | 1 |
| 2014 | 1 |
| 2015 | 1 |
| 2020 | 1 |
| 2021 | 1 |
| 2022 | 1 |
| 2023 | 2 |
| 2024 | 2 |
| 2025 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K250894 | Eminent Spine Posterior SI System | OUR | Substantially Equivalent | |
| K241663 | Eminent Spine 3D Titanium Pedicle Screw System | NKB | Substantially Equivalent | |
| K242069 | Eminent Spine Scoliosis Deformity Pedicle Screw System | NKB | Substantially Equivalent | |
| K240505 | Eminent Spine SI Screw System | OUR | Substantially Equivalent | |
| K230219 | Eminent Spine 3D Lumbar Interbody Fusion Systems | MAX | Substantially Equivalent | |
| K212701 | Eminent Spine 3D Cervical Interbody Fusion System | ODP | Substantially Equivalent | |
| K221936 | Standalone ALIF Interbody Fusion System | OVD | Substantially Equivalent | |
| K212853 | Cervical Stand-Alone System | OVE | Substantially Equivalent | |
| K201979 | Cervical Plate System | KWQ | Substantially Equivalent | |
| K143365 | Eminent Foot Plate System | HRS | Substantially Equivalent | |
| K133194 | DIAMOND RATTLESNAKE SYSTEM | KWQ | Substantially Equivalent | |
| K103068 | KING COBRA ANTERIOR CERVICAL PLATE | KWQ | Substantially Equivalent | |
| K100377 | DIAMONDBACK SPINAL SYSTEM | MNI | Substantially Equivalent | |
| K090415 | EMINENT SPINE BUTTRESS (FANG) PLATE SYSTEM | KWQ | Substantially Equivalent | |
| K090064 | EMINENT SPINE INTERBODY FUSION SYSTEM | MAX | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KWQAppliance, Fixation, Spinal Intervertebral Body
- ODPIntervertebral Fusion Device With Bone Graft, Cervical
- MAXIntervertebral Fusion Device With Bone Graft, Lumbar
- OVEIntervertebral Fusion Device With Integrated Fixation, Cervical
- OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar
- MNIOrthosis, Spinal Pedicle Fixation
- HRSPlate, Fixation, Bone
- OURSacroiliac Joint Fixation
- 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