Medical Device Manufacturer · US , Leander , TX

Eminent Spine

11 submissions · 11 cleared · Since 2009
11
Total
11
Cleared
0
Denied

Eminent Spine — FDA 510(k) Submissions

Eminent Spine has submitted 11 FDA 510(k) premarket notifications since 2009, of which 11 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Appliance, Fixation, Spinal Intervertebral Body, Thoracolumbosacral Pedicle Screw System, Plate, Fixation, Bone, Intervertebral Fusion Device With Bone Graft, Cervical, Intervertebral Fusion Device With Integrated Fixation, Lumbar . Use the specialty filter in the sidebar to narrow results.

11 devices
1–11 of 11
Eminent Spine Posterior SI System
K250894 · OUR Sacroiliac Joint Fixation · Orthopedic
Oct 2025 196d
Eminent Spine 3D Titanium Pedicle Screw System
K241663 · NKB Thoracolumbosacral... · Orthopedic
Apr 2025 325d
Eminent Spine Scoliosis Deformity Pedicle Screw System
K242069 · NKB Thoracolumbosacral... · Orthopedic
Sep 2024 50d
Eminent Spine 3D Cervical Interbody Fusion System
K212701 · ODP Intervertebral Fusion... · Orthopedic
Feb 2023 530d
Standalone ALIF Interbody Fusion System
K221936 · OVD Intervertebral Fusion... · Orthopedic
Oct 2022 108d
Eminent Foot Plate System
K143365 · HRS Plate, Fixation, Bone · Orthopedic
Mar 2015 126d
DIAMOND RATTLESNAKE SYSTEM
K133194 · KWQ Appliance, Fixation,... · Orthopedic
Jun 2014 252d
KING COBRA ANTERIOR CERVICAL PLATE
K103068 · KWQ Appliance, Fixation,... · Orthopedic
Jan 2011 88d
DIAMONDBACK SPINAL SYSTEM
K100377 · MNI Orthosis, Spinal Pedicle... · Orthopedic
Apr 2010 69d
EMINENT SPINE BUTTRESS (FANG) PLATE SYSTEM
K090415 · KWQ Appliance, Fixation,... · Orthopedic
Jun 2009 103d
EMINENT SPINE INTERBODY FUSION SYSTEM
K090064 · MAX Intervertebral Fusion... · Orthopedic
Apr 2009 90d
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