Data / Medical devices / Taiwan / Taiwan Main Orthopaedic Biotechnology Co., Ltd
Taiwan Main Orthopaedic Biotechnology Co., Ltd: FDA-registered device maker in Taichung City, Taiwan, 3 510(k) clearances
Taiwan Main Orthopaedic Biotechnology Co., Ltd is registered with the FDA (registration 3014232530) in Taichung City, Taiwan. It lists 5 device types. The FDA files 3 510(k) clearances under its listings, the newest dated September 15, 2026. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3014232530
- Address
- 2F., No.41, Keya Rd. Daya Dist., Taichung City, Taiwan, 428015
- Owner or operator
- Taiwan Main Orthopaedic Biotechnology Co., Ltd. (10058896)
- Roles
- Manufacturer
- First device listed
- November 7, 2018
- Registered through
- 2027
- Brand names listed
- Asclepius AI Table (TBK-AI-84 Ultra, TBK-AI-65 Vision 4K), Asclepius Radiology (TBK 99EA, TBK 99, TBK 84, TBK 84EA, TBK 65 4K, TBK 43LT), Caduceus S, Foresee-X, OOOPDS
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Digital Image Storage, Radiological | LMB | 1 | Manufacturer | accessdata.fda.gov |
| Device, Storage, Images, Ophthalmic | NFF | 1 | Manufacturer | accessdata.fda.gov |
| Orthopedic Augmented Reality | SBF | 2 | Manufacturer | accessdata.fda.gov |
| System, Digital Image Communications, Radiological | LMD | 1 | Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| September 15, 2026 | K254214 | OOOPDS | LLZ | Substantially Equivalent | Taiwan Main Orthopaedic Biotechnology Co., Ltd. | accessdata.fda.gov |
| October 30, 2024 | K242271 | Caduceus S | SBF | Substantially Equivalent | Taiwan Main Orthopaedic Biotechnology Co., Ltd. | accessdata.fda.gov |
| December 16, 2022 | K220554 | Caduceus S | SBF | Substantially Equivalent | Taiwan Main Orthopaedic Biotechnology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Digital Image Communications, Radiological
- All makers of Device, Digital Image Storage, Radiological
- All makers of Orthopedic Augmented Reality
- All makers of System, Image Processing, Radiological
- All makers of Device, Storage, Images, Ophthalmic
Updated September 15, 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.