The following data is part of a premarket notification filed by Intai Technology Corporation with the FDA for Intai Anatomic Locking Plate And Screw System.
| Device ID | K201229 |
| 510k Number | K201229 |
| Device Name: | Intai Anatomic Locking Plate And Screw System |
| Classification | Plate, Fixation, Bone |
| Applicant | Intai Technology Corporation No. 9 Jingke Rd., Nantun Dist. Taichung, TW 40852 |
| Contact | Dale Chang |
| Correspondent | Dale Chang Intai Technology Corporation No. 9 Jingke Rd., Nantun Dist. Taichung, TW 40852 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-07 |
| Decision Date | 2022-03-11 |