The following data is part of a premarket notification filed by Intai Technology Corporation with the FDA for Intai Surgery Navigation System.
| Device ID | K180523 |
| 510k Number | K180523 |
| Device Name: | INTAI Surgery Navigation System |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | Intai Technology Corporation No. 9 Jingke Rd., Nantun Dist., Taichung City, TW 40852 |
| Contact | Shih-chang Chuang |
| Correspondent | Shih-chang Chuang Intai Technology Corporation No. 9 Jingke Rd., Nantun Dist., Taichung City, TW 40852 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-27 |
| Decision Date | 2019-09-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719876757807 | K180523 | 000 |
| 04719876737274 | K180523 | 000 |
| 04719876737267 | K180523 | 000 |