# Tedan Surgical Innovations, LLC

- Location (FDA's records): Sugar Land, TX
- FDA decisions: 4 (2014–2026): 4 510(k) clearances
- Names in FDA's records: Tedan Surgical Innovations, LLC (2); TeDan Surgical Innovations, Inc. (1); Tedan Surgical Innovations (1)
- Product codes: PDQ (2), GXZ (1), GZT (1)
- Predicates its devices cite: 3 (2 its own); citations of its devices by later devices: 2 (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
- Stryker Spine: 1 (https://510kreport.com/company/stryker-spine)

## Its most-cited devices
- K231691: Phantom XL Insulated Dilators (2023), cited by 1
- K140088: Phantom XL Insulated Dilators (2014), cited by 1

## Recent decisions
- K253580: Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S) (Apr 26, 2026)
- K231691: Phantom XL Insulated Dilators (Jun 29, 2023)
- K161318: Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems (Mar 20, 2017)
- K140088: Phantom XL Insulated Dilators (Sep 25, 2014)

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