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Data / Medical devices / United States / Eminent Spine, LLC

Eminent Spine, LLC: FDA-registered device maker in Plano, TX, United States, 15 510(k) clearances

Eminent Spine, LLC is registered with the FDA (registration 3007345964) in Plano, TX, United States. It lists 13 device types. The FDA files 15 510(k) clearances under its listings, the newest dated October 7, 2025. Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this oneWatch Eminent Spine, LLC
FDA registration number
3007345964
Address
2004 Ventura Dr Ste 250, Plano, TX, United States, 75093
Owner or operator
Eminent Spine, LLC (10028153)
Roles
Contract manufacturer, Manufacturer
First device listed
June 29, 2009
Registered through
2027
Brand names listed
Anterior Cervical Plate System, Black/Red Diamond Rattlesnake Lumbar Plating System, Cervical Plate System, Cervical Stand-Alone System, Diamond Rattlesnake System, Diamondback Spinal System, Eminent Cervical Stand-Alone System, Eminent Foot Plate System and more

Devices it lists

DeviceProduct codeClassRoleSource
Appliance, Fixation, Spinal Intervertebral BodyKWQ2Manufactureraccessdata.fda.gov
Implant, Endosseous, OrthodonticOAT2Manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, CervicalODP2Manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, LumbarMAX2Manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, CervicalOVE2Manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, LumbarOVD2Manufactureraccessdata.fda.gov
Orthosis, Spinal Pedicle FixationMNI2Manufactureraccessdata.fda.gov
Orthosis, Spondylolisthesis Spinal FixationMNH2Manufactureraccessdata.fda.gov
Plate, Fixation, BoneHRS2Contract manufactureraccessdata.fda.gov
Sacroiliac Joint FixationOUR2Manufactureraccessdata.fda.gov
Screw, Fixation, BoneHWC2Contract manufactureraccessdata.fda.gov
Spinal Vertebral Body Replacement DeviceMQP2Manufactureraccessdata.fda.gov
Thoracolumbosacral Pedicle Screw SystemNKB2Manufactureraccessdata.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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
October 7, 2025K250894Eminent Spine Posterior SI SystemOURSubstantially EquivalentEminent Spineaccessdata.fda.gov
April 28, 2025K241663Eminent Spine 3D Titanium Pedicle Screw SystemNKBSubstantially EquivalentEminent Spineaccessdata.fda.gov
September 3, 2024K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemNKBSubstantially EquivalentEminent Spineaccessdata.fda.gov
June 4, 2024K240505Eminent Spine SI Screw SystemOURSubstantially EquivalentEminent Spine, LLCaccessdata.fda.gov
May 16, 2023K230219Eminent Spine 3D Lumbar Interbody Fusion SystemsMAXSubstantially EquivalentEminent Spine, LLCaccessdata.fda.gov
February 6, 2023K212701Eminent Spine 3D Cervical Interbody Fusion SystemODPSubstantially EquivalentEminent Spineaccessdata.fda.gov
October 17, 2022K221936Standalone ALIF Interbody Fusion SystemOVDSubstantially EquivalentEminent Spineaccessdata.fda.gov
November 5, 2021K212853Cervical Stand-Alone SystemOVESubstantially EquivalentEminent Spine, LLCaccessdata.fda.gov
December 17, 2020K201919Blue Sky Bio TADOATSubstantially EquivalentBlue Sky Bio, LLCaccessdata.fda.gov
August 25, 2020K201979Cervical Plate SystemKWQSubstantially EquivalentEminent Spine, LLCaccessdata.fda.gov
June 26, 2014K133194DIAMOND RATTLESNAKE SYSTEMKWQSubstantially EquivalentEminent Spineaccessdata.fda.gov
January 14, 2011K103068KING COBRA ANTERIOR CERVICAL PLATEKWQSubstantially EquivalentEminent Spineaccessdata.fda.gov
April 22, 2010K100377DIAMONDBACK SPINAL SYSTEMMNISubstantially EquivalentEminent Spineaccessdata.fda.gov
June 1, 2009K090415EMINENT SPINE BUTTRESS (FANG) PLATE SYSTEMKWQSubstantially EquivalentEminent Spineaccessdata.fda.gov
April 9, 2009K090064EMINENT SPINE INTERBODY FUSION SYSTEMMAXSubstantially EquivalentEminent Spineaccessdata.fda.gov

Compare with other makers

Updated October 7, 2025. 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.