# Sintea Plastek, LLC

- Location (FDA's records): Miami Beach, FL
- FDA decisions: 2 (2011–2012): 2 510(k) clearances
- Product codes: MNI (1), MQP (1)
- Predicates its devices cite: 2 (0 its own); citations of its devices by later devices: 0 (0 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
- Sintea Biotech, Inc.: 2 (https://510kreport.com/company/sintea-biotech)

## Recent decisions
- K112611: Sintea Plustek PLS Multi-Axial Screws (Apr 25, 2012)
- K101886: DSC/Alf Spinal System (Jul 21, 2011)

Source page: https://510kreport.com/company/sintea-plastek