# Intelligent Implant Systems, LLC

- Location (FDA's records): Charlotte, NC
- FDA decisions: 6 (2012–2018): 6 510(k) clearances
- Product codes: NKB (3), HWC (1), KWP (1), KWQ (1)
- 510(k) review time since 2016: median 111 days, against 84 for FDA's reviews in the same codes and years (0 of 3 faster)
- Predicates its devices cite: 20 (3 its own); citations of its devices by later devices: 3 (3 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 Innovations, LLC: 4 (https://510kreport.com/company/spinal-innovations)
- Synthes (Usa): 3 (https://510kreport.com/company/synthes-usa)
- Wrightmedicaltechnologyinc: 2 (https://510kreport.com/company/wrightmedicaltechnologyinc)
- Life Spine, Inc.: 2 (https://510kreport.com/company/life-spine)
- Medtronic Sofamor Danek: 2 (https://510kreport.com/company/medtronic-sofamor-danek)
- Whiteside Biomechanics, Inc.: 1 (https://510kreport.com/company/whiteside-biomechanics)
- Aesculap, Inc.: 1 (https://510kreport.com/company/aesculap)
- K2m, Inc.: 1 (https://510kreport.com/company/k2m)

## Its most-cited devices
- K142939: Revolution Spinal Fixation System (2015), cited by 2
- K160216: Revolution Spinal Fixation System (2016), cited by 1

## Recent decisions
- K173935: Mediant Anterior Cervical Plating System (Apr 16, 2018)
- K163056: Revolution™ Spinal Fixation System (Feb 24, 2017)
- K160216: Revolution Spinal Fixation System (Apr 22, 2016)
- K142939: Revolution Spinal Fixation System (Jan 13, 2015)
- K132900: Marauder Cervical-Thoracic Spinal Fixation System (Oct 25, 2013)
- K121682: Active Screw Bone Screw (Oct 4, 2012)

Source page: https://510kreport.com/company/intelligent-implant-systems