510(k) Report

FDA applicant

Intai Technology Corporation

Taichung, TW5 decisions2006–20220 recalls

FDA records 5 decisions for Intai Technology Corporation (Taichung, TW) from 2006 to 2022: 5 510(k) clearances. Most are in product codes HRS (Plate, Fixation, Bone) and OLO (Orthopedic Stereotaxic Instrument). Since 2016 its 510(k)s took a median of 570 days from receipt to decision, against 113 for FDA’s reviews in the same codes and years. Its devices cite 21 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Intai Technology Corp.”, “Intai Technology, Inc.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided Intai Technology Corporation’s devices, and how often a recall has named them.

FDA decisions per year

2in 2022

2013: 12019: 12022: 2
2007high 2 (2022) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Intai Technology Corporation by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Intai Technology Corporation’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • HRSPlate, Fixation, Bone2decisions
  • OLOOrthopedic Stereotaxic Instrument1decision
  • DZEImplant, Endosseous, Root-Form1decision
  • FXXMask, Surgical1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 570 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 113 days; 0 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 21 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K180523INTAI Surgery Navigation SystemIntai Technology Corporation · 20194cite it
  • K063020Intai Bone Plate and Bone Screw System; Intai DHS/DCS Plate SystemIntai Technology, Inc. · 20063cite it

What has FDA decided for it lately?

  • K210422INTAI Surgical Mask (non-sterile)Intai Technology Corp. · 2022
  • K201229Intai Anatomic Locking Plate and Screw SystemIntai Technology Corporation · 2022
  • K180523INTAI Surgery Navigation SystemIntai Technology Corporation · 2019
  • K122804Royal-Dent Eureka Dental Implant SystemIntai Technology Corp. · 2013
  • K063020Intai Bone Plate and Bone Screw System; Intai DHS/DCS Plate SystemIntai Technology, Inc. · 2006

All 2 as Intai Technology Corporation →All 2 as Intai Technology Corp. →The one decision as Intai Technology, Inc. →