# Eminent Spine

- Location (FDA's records): Plano, TX
- FDA decisions: 15 (2009–2025): 15 510(k) clearances
- Names in FDA's records: Eminent Spine (11); Eminent Spine, LLC (4)
- Product codes: KWQ (4), NKB (2), OUR (2), MAX (2), ODP (1), MNI (1), OVE (1), OVD (1), HRS (1)
- 510(k) review time since 2016: median 108 days, against 87 for FDA's reviews in the same codes and years (4 of 9 faster)
- Predicates its devices cite: 53 (7 its own); citations of its devices by later devices: 59 (7 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Medtronic Sofamor Danek USA, Inc.: 5 (https://510kreport.com/company/medtronic-sofamor-danek-usa)
- Depuyacromed: 4 (https://510kreport.com/company/depuyacromed)
- Osteomed LP: 4 (https://510kreport.com/company/osteomed)
- Nuvasive, Inc.: 3 (https://510kreport.com/company/nuvasive)
- Buckman Co., Inc.: 2 (https://510kreport.com/company/buckman)
- Cross Medical Products, Inc.: 2 (https://510kreport.com/company/cross-medical-products)
- Synthes (Usa): 2 (https://510kreport.com/company/synthes-usa)
- Corelink, LLC: 2 (https://510kreport.com/company/corelink)

## Firms that cite its devices most
- Spinefrontier, Inc.: 4 (https://510kreport.com/company/spinefrontier)
- Evolution Spine: 3 (https://510kreport.com/company/evolution-spine)
- Genesys Spine: 3 (https://510kreport.com/company/genesys-spine)
- Spinecraft, LLC: 3 (https://510kreport.com/company/spinecraft)
- K7, LLC: 2 (https://510kreport.com/company/k7)
- Republic Spine, LLC: 2 (https://510kreport.com/company/republic-spine)
- Bm Korea Co., Ltd.: 2 (https://510kreport.com/company/bm-korea)
- Southern Medical (Pty), Ltd.: 2 (https://510kreport.com/company/southern-medical)

## Its most-cited devices
- K090064: Eminent Spine Interbody Fusion System (2009), cited by 34
- K212853: Cervical Stand-Alone System (2021), cited by 5
- K100377: Diamondback Spinal System (2010), cited by 4
- K090415: Eminent Spine Buttress (Fang) Plate System (2009), cited by 3
- K133194: Diamond Rattlesnake System (2014), cited by 3
- K212701: Eminent Spine 3D Cervical Interbody Fusion System (2023), cited by 2

## Recent decisions
- K250894: Eminent Spine Posterior SI System (Oct 7, 2025)
- K241663: Eminent Spine 3D Titanium Pedicle Screw System (Apr 28, 2025)
- K242069: Eminent Spine Scoliosis Deformity Pedicle Screw System (Sep 3, 2024)
- K240505: Eminent Spine SI Screw System (Jun 4, 2024)
- K230219: Eminent Spine 3D Lumbar Interbody Fusion Systems (May 16, 2023)
- K212701: Eminent Spine 3D Cervical Interbody Fusion System (Feb 6, 2023)
- K221936: Standalone ALIF Interbody Fusion System (Oct 17, 2022)
- K212853: Cervical Stand-Alone System (Nov 5, 2021)

Source page: https://510kreport.com/company/eminent-spine