# Engage Uni, LLC

- Location (FDA's records): Winter Park, FL
- FDA decisions: 1 (2019–2019): 1 510(k) clearance
- Product codes: NJD (1)
- Predicates its devices cite: 1 (0 its own); citations of its devices by later devices: 2 (0 its own)
- Recalls linked to its devices: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Mako Surgical Corp.: 1 (https://510kreport.com/company/mako-surgical)

## Firms that cite its devices most
- Smith & Nephew, Inc.: 2 (https://510kreport.com/company/smith-nephew)

## Its most-cited devices
- K190439: Engage™ Partial Knee System (2019), cited by 2

## Recent decisions
- K190439: Engage™ Partial Knee System (Nov 21, 2019)

Source page: https://510kreport.com/company/engage-uni