Intai Technology Corp.
Taichung City, TW
INTAI TECHNOLOGY CORP. appears in FDA device records in Taichung City, TW. FDA records list 5 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 5 510(k) clearances for Intai Technology Corp. between 2006 and 2022. The busiest year on record is 2022, with 2. The most recent is 2022, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2006 | 1 |
| 2013 | 1 |
| 2019 | 1 |
| 2022 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K210422 | INTAI Surgical Mask (non-sterile) | FXX | Substantially Equivalent | |
| K201229 | Intai Anatomic Locking Plate and Screw System | HRS | Substantially Equivalent | |
| K180523 | INTAI Surgery Navigation System | OLO | Substantially Equivalent | |
| K122804 | ROYAL-DENT EUREKA DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | |
| K063020 | INTAI BONE PLATE AND BONE SCREW SYSTEM; INTAI DHS/DCS PLATE SYSTEM | HRS | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3004450679 | 3004450679 | INTAI TECHNOLOGY CORP. | 9 JINGKE ROAD, NANTUN DISTRICT, TAICHUNG CITY 40852 TW | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain