Data / Medical devices / Taiwan / Remex Medical Corp.
Remex Medical Corp.: FDA-registered device maker in Taichung, Taiwan, 8 510(k) clearances
Remex Medical Corp. is registered with the FDA (registration 3017823294) in Taichung, Taiwan. It lists 5 device types. The FDA files 8 510(k) clearances under its listings, the newest dated August 20, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3017823294
- Address
- 4F., No. 9, Jingke Road, Nantun Dist., Taichung, Taiwan, 408224
- Owner or operator
- Remex Medical Corp. (10078678)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- November 1, 2020
- Registered through
- 2027
- Brand names listed
- Anatase Navi Disposable Instrument, Anatase Spine Surgery Navigation System, Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II, Anatase Surgery Navigation System, Anatase spine navigation instrument, Bone Pin, Drill bit, Driver and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bit, Drill | HTW | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Orthopedic Stereotaxic Instrument | OLO | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Orthopedic Tray | OJH | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Wrench | HXC | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 20, 2026 | K262506 | Remex Spine Surgery Navigation - Universal Instruments | OLO | Substantially Equivalent | Remex Medical Corp. | accessdata.fda.gov |
| May 29, 2025 | K251315 | Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II | OLO | Substantially Equivalent | Remex Medical Corp. | accessdata.fda.gov |
| December 13, 2024 | K243560 | Remex Spine Surgery Navigation Instrument | OLO | Substantially Equivalent | Remex Medical Corp. | accessdata.fda.gov |
| July 5, 2024 | K241625 | Anatase Navi Disposable Instrument | OLO | Substantially Equivalent | Remex Medical Corp. | accessdata.fda.gov |
| May 1, 2024 | K233513 | Remex Spine Surgery Navigation System II | OLO | Substantially Equivalent | Remex Medical Corp. | accessdata.fda.gov |
| April 21, 2023 | K230783 | Anatase Spine Surgery Navigation System | OLO | Substantially Equivalent | Remex Medical Corp. | accessdata.fda.gov |
| July 14, 2022 | K220348 | Anatase Spine Surgery Navigation System, Model number: SNS-Spine2-S and SNS-spine2-V | OLO | Substantially Equivalent | Remex Medical Corporation | accessdata.fda.gov |
| September 20, 2019 | K180523 | INTAI Surgery Navigation System | OLO | Substantially Equivalent | Intai Technology Corporation | accessdata.fda.gov |
Compare with other makers
- All makers of Wrench
- All makers of Bit, Drill
- All makers of Orthopedic Stereotaxic Instrument
- All makers of Orthopedic Manual Surgical Instrument
- All makers of Orthopedic Tray
Updated August 20, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.