# Avalign Technologies, Inc.

- Location (FDA's records): Fort Wayne, IN
- FDA decisions: 3 (2020–2026): 3 510(k) clearances
- Product codes: OVD (1), KCT (1), OVE (1)
- 510(k) review time since 2016: median 274 days, against 100 for FDA's reviews in the same codes and years (0 of 3 faster)
- Predicates its devices cite: 10 (1 its own); citations of its devices by later devices: 1 (1 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
- Eit Emerging Implant Technologies GmbH: 4 (https://510kreport.com/company/eit-emerging-implant-technologies)
- Synthes (USA) Products, LLC: 1 (https://510kreport.com/company/synthes-usa-products)
- Stryker Corp.: 1 (https://510kreport.com/company/stryker)
- Medtronic Sofamor Danek USA, Inc.: 1 (https://510kreport.com/company/medtronic-sofamor-danek-usa)
- Synthes Spine: 1 (https://510kreport.com/company/synthes-spine)
- Globus Medical, Inc.: 1 (https://510kreport.com/company/globus-medical)

## Its most-cited devices
- K250072: CONDUIT™ SYNFIX™ Evolution Secured Spacer System (2025), cited by 1

## Recent decisions
- K252982: CONDUIT™ ZERO-P™ VA Secured Spacer System (Jun 18, 2026)
- K250072: CONDUIT™ SYNFIX™ Evolution Secured Spacer System (Jul 10, 2025)
- K193066: Steripack cases and Tray Systems (Aug 6, 2020)

Source page: https://510kreport.com/company/avalign-technologies