# Intai Technology Corporation

- Location (FDA's records): Taichung, TW
- FDA decisions: 5 (2006–2022): 5 510(k) clearances
- Names in FDA's records: Intai Technology Corporation (2); Intai Technology Corp. (2); Intai Technology, Inc. (1)
- Product codes: HRS (2), OLO (1), DZE (1), FXX (1)
- 510(k) review time since 2016: median 570 days, against 113 for FDA's reviews in the same codes and years (0 of 3 faster)
- Predicates its devices cite: 21 (0 its own); citations of its devices by later devices: 7 (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
- Synthes (Usa): 12 (https://510kreport.com/company/synthes-usa)
- Zimmer, Inc.: 2 (https://510kreport.com/company/zimmer)
- Osstem Implant Co., Ltd.: 2 (https://510kreport.com/company/osstem-implant)
- Syntec Scientific Corp.: 2 (https://510kreport.com/company/syntec-scientific)
- Stryker Leibinger GmbH & Co KG: 1 (https://510kreport.com/company/stryker-leibinger)
- Medtronic Navigation, Inc.: 1 (https://510kreport.com/company/medtronic-navigation)
- Qingdao Hainuo Biological Engineering Co., Ltd.: 1 (https://510kreport.com/company/qingdao-hainuo-biological-engineering)

## Firms that cite its devices most
- Remex Medical Corp.: 4 (https://510kreport.com/company/remex-medical)
- Kens Finemedtech Sdn. Bhd: 1 (https://510kreport.com/company/kens-finemedtech-sdn-bhd)
- Tdm Co., Ltd.: 1 (https://510kreport.com/company/tdm)
- Microware Precision Co., Ltd.: 1 (https://510kreport.com/company/microware-precision)

## Its most-cited devices
- K180523: INTAI Surgery Navigation System (2019), cited by 4
- K063020: Intai Bone Plate and Bone Screw System; Intai DHS/DCS Plate System (2006), cited by 3

## Recent decisions
- K210422: INTAI Surgical Mask (non-sterile) (Mar 30, 2022)
- K201229: Intai Anatomic Locking Plate and Screw System (Mar 11, 2022)
- K180523: INTAI Surgery Navigation System (Sep 20, 2019)
- K122804: Royal-Dent Eureka Dental Implant System (May 20, 2013)
- K063020: Intai Bone Plate and Bone Screw System; Intai DHS/DCS Plate System (Dec 14, 2006)

Source page: https://510kreport.com/company/intai-technology