# Simbionix, Ltd.

- Location (FDA's records): Chalotte, NC
- FDA decisions: 3 (2010–2013): 3 510(k) clearances
- Product codes: LLZ (3)
- Predicates its devices cite: 5 (2 its own); citations of its devices by later devices: 7 (2 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
- Materialise NV: 2 (https://510kreport.com/company/materialise)
- Shina Systems, Ltd.: 1 (https://510kreport.com/company/shina-systems)

## Firms that cite its devices most
- 3Dsystems, Simbionix Products: 3 (https://510kreport.com/company/3dsystems-simbionix-products)
- Surgical Theater, LLC: 1 (https://510kreport.com/company/surgical-theater)
- Immersivetouch: 1 (https://510kreport.com/company/immersivetouch)

## Its most-cited devices
- K112387: Procedure Rehearsal Studio (TM) (2011), cited by 4
- K093269: Procedure Rehearsal Studio (2010), cited by 2
- K123269: Procedure Rehearsal Studio (2013), cited by 1

## Recent decisions
- K123269: Procedure Rehearsal Studio (Jan 29, 2013)
- K112387: Procedure Rehearsal Studio (TM) (Dec 27, 2011)
- K093269: Procedure Rehearsal Studio (Aug 20, 2010)

Source page: https://510kreport.com/company/simbionix