# Coalign Innovations, Inc.

- Location (FDA's records): Washington, DC
- FDA decisions: 9 (2011–2013): 9 510(k) clearances
- Product codes: MAX (9)
- Predicates its devices cite: 21 (13 its own); citations of its devices by later devices: 36 (13 its own)
- Recalls linked to its devices: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Innvotec Surgical, Inc.: 5 (https://510kreport.com/company/innvotec-surgical)
- Globus Medical, Inc.: 2 (https://510kreport.com/company/globus-medical)
- Medtronic Sofamor Danek USA, Inc.: 1 (https://510kreport.com/company/medtronic-sofamor-danek-usa)

## Firms that cite its devices most
- Neurostructures, Inc.: 3 (https://510kreport.com/company/neurostructures)
- Expanding Orthopedics, Inc.: 3 (https://510kreport.com/company/expanding-orthopedics)
- Spectrum Spine, LLC: 3 (https://510kreport.com/company/spectrum-spine)
- Exactech, Inc.: 2 (https://510kreport.com/company/exactech)
- Life Spine, Inc.: 1 (https://510kreport.com/company/life-spine)
- Stryker Corp.: 1 (https://510kreport.com/company/stryker)
- Met One Technologies, LLC: 1 (https://510kreport.com/company/met-one-technologies)
- Innovasive, Inc.: 1 (https://510kreport.com/company/innovasive)

## Its most-cited devices
- K112095: Acculif TL-Peek Ibf Cage (2011), cited by 11
- K123281: Acculif TL-Peek Cage (2013), cited by 7
- K123752: Acculif TL and PL Cage (2013), cited by 6
- K113465: Acculif TL Cage (2011), cited by 5
- K110270: Acculif Cage (2011), cited by 2
- K132505: Acculif TL and PL Cage (2013), cited by 2

## Recent decisions
- K132505: Acculif TL and PL Cage (Sep 12, 2013)
- K131443: Coalign Innovations Acculif XL Ibf Cage (Jun 19, 2013)
- K130194: Acculif XL Cage (Apr 3, 2013)
- K123281: Acculif TL-Peek Cage (Jan 23, 2013)
- K123752: Acculif TL and PL Cage (Jan 14, 2013)
- K121683: Acculif TL Cage (Jul 5, 2012)
- K113465: Acculif TL Cage (Dec 12, 2011)
- K112095: Acculif TL-Peek Ibf Cage (Dec 1, 2011)

Source page: https://510kreport.com/company/coalign-innovations