# Cutting Edge Spine, LLC

- Location (FDA's records): Waxhaw, NC
- FDA decisions: 11 (2011–2025): 11 510(k) clearances
- Product codes: MAX (6), OUR (3), ODP (2)
- 510(k) review time since 2016: median 30 days, against 106 for FDA's reviews in the same codes and years (6 of 9 faster)
- Predicates its devices cite: 31 (14 its own); citations of its devices by later devices: 21 (14 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Spinal Elements, Inc.: 2 (https://510kreport.com/company/spinal-elements)
- Medtronic Sofamor Danek USA, Inc.: 2 (https://510kreport.com/company/medtronic-sofamor-danek-usa)
- Nu Vasive, Incorporated: 2 (https://510kreport.com/company/nu-vasive)
- Tyber Medical, LLC: 1 (https://510kreport.com/company/tyber-medical)
- Medacta International S.A.: 1 (https://510kreport.com/company/medacta-international)
- Synthes (Usa): 1 (https://510kreport.com/company/synthes-usa)
- Orthofix, Inc.: 1 (https://510kreport.com/company/orthofix)
- Sij Surgical: 1 (https://510kreport.com/company/sij-surgical)

## Firms that cite its devices most
- Keos: 1 (https://510kreport.com/company/keos)
- Spineology, Inc.: 1 (https://510kreport.com/company/spineology)
- Astura Medical: 1 (https://510kreport.com/company/astura-medical)
- Curiteva, Inc.: 1 (https://510kreport.com/company/curiteva)
- Pinnacle Spine Group, LLC: 1 (https://510kreport.com/company/pinnacle-spine-group)
- Ht Medical, LLC: 1 (https://510kreport.com/company/ht-medical)
- Precision Spine, Inc.: 1 (https://510kreport.com/company/precision-spine)

## Its most-cited devices
- K150321: EVOS Lumbar Interbody System (2015), cited by 9
- K102957: Cutting Edge Spine Interbody Fusion Device (2011), cited by 5
- K190025: EVOL® -SI Joint Fusion System (2019), cited by 2
- K180674: EVOL® ha-C Cervical Interbody Fusion System (2018), cited by 2
- K214123: T-FIX® 3DSI Joint Fusion System (2022), cited by 1
- K180891: EVOL Spinal Interbody System, EVOS Lumbar Interbody System (2018), cited by 1

## Recent decisions
- K250605: EVOL® ha – Hyper C Cervical Interbody Fusion System (Mar 12, 2025)
- K230689: T-FIX™ 3DSI Joint Fusion System (Apr 5, 2023)
- K214123: T-FIX® 3DSI Joint Fusion System (Jun 24, 2022)
- K200991: EVOL Spinal Interbody System (May 13, 2020)
- K200552: EVOS Lumbar Interbody System (Apr 2, 2020)
- K192497: EVOL ha - D Lateral Interbody Fusion System (Jan 6, 2020)
- K190025: EVOL® -SI Joint Fusion System (Aug 12, 2019)
- K180674: EVOL® ha-C Cervical Interbody Fusion System (Jun 25, 2018)

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