Chrysalis Intelligence · Sponsors · Eminent Spine

Eminent Spine

Plano, TX, US · 9 510(k) clearances

Total clearances
9
2020-08-25 → 2025-10-07
Last 12 months
1
Product codes
7
Most recent
2025-10-07
Name variants in FDA filings: Eminent Spine / Eminent Spine, LLC
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
OUR Sacroiliac Joint Fixation Class II Orthopedic 2 2025-10-07
NKB Thoracolumbosacral Pedicle Screw System Class II Orthopedic 2 2025-04-28
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Class II Orthopedic 1 2023-05-16
ODP Intervertebral Fusion Device With Bone Graft, Cervical Class II Orthopedic 1 2023-02-06
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Class II Orthopedic 1 2022-10-17
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Class II Orthopedic 1 2021-11-05
KWQ Appliance, Fixation, Spinal Intervertebral Body Class II Orthopedic 1 2020-08-25
Filings

All 510(k) clearances (9)

Date K-number Device Code Class Specialty
2025-10-07 K250894 Eminent Spine Posterior SI System OUR Class II Orthopedic
2025-04-28 K241663 Eminent Spine 3D Titanium Pedicle Screw System NKB Class II Orthopedic
2024-09-03 K242069 Eminent Spine Scoliosis Deformity Pedicle Screw System NKB Class II Orthopedic
2024-06-04 K240505 Eminent Spine SI Screw System OUR Class II Orthopedic
2023-05-16 K230219 Eminent Spine 3D Lumbar Interbody Fusion Systems MAX Class II Orthopedic
2023-02-06 K212701 Eminent Spine 3D Cervical Interbody Fusion System ODP Class II Orthopedic
2022-10-17 K221936 Standalone ALIF Interbody Fusion System OVD Class II Orthopedic
2021-11-05 K212853 Cervical Stand-Alone System OVE Class II Orthopedic
2020-08-25 K201979 Cervical Plate System KWQ Class II Orthopedic