Data / Medical devices / Taiwan / Ossaware Biotech Co., Ltd.
Ossaware Biotech Co., Ltd.: FDA-registered device maker in Shenkang Hsiang Changhua, Taiwan, 1 510(k) clearance
Ossaware Biotech Co., Ltd. is registered with the FDA (registration 3013340866) in Shenkang Hsiang Changhua, Taiwan. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 3, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013340866
- Address
- No. 51, Xinggong Rd., Shenkang Hsiang Changhua, Taiwan, 50971
- Owner or operator
- OSSAWARE BIOTECH CO., LTD. (10075919)
- Roles
- Manufacturer
- First device listed
- July 13, 2020
- Registered through
- 2026
- Brand names listed
- 9900001.15S connectCMF Flap Fixator, Replaceable Type+Screwdriver, PEEK, D15mm, Sterile, 9900002.20S connectCMF Flap Fixator, Replaceable Type+Screwdriver, PEEK, D20mm, Sterile, 9900003.16S connectCMF Flap Fixator, Replaceable Type+Screwdriver, PEEK, D16mm, Sterile, 9900004.22S connectCMF Flap Fixator, Replaceable Type+Screwdriver, PEEK, D22mm, Sterile, 9900101.15S connectCMF Flap Fixator, Replaceable Type+Screwdriver, PEEK, D15mm, Sterile, 9900102.20S connectCMF Flap Fixator, Replaceable Type+Screwdriver, PEEK, D20mm, Sterile, 9900103.16S connectCMF Flap Fixator, Replaceable Type+Screwdriver, PEEK, D16mm, Sterile, 9900104.22S connectCMF Flap Fixator, Replaceable Type+Screwdriver, PEEK, D22mm, Sterile and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory, Surgical Apparel | LYU | 1 | Manufacturer | accessdata.fda.gov |
| Cover, Burr Hole | GXR | 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 |
|---|---|---|---|---|---|---|
| June 3, 2020 | K192310 | Flap Fixator, Burr Hole Cover | GXR | Substantially Equivalent | Ossaware Biotech Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated June 3, 2020. 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.