Data / Medical devices / Taiwan / Wiltrom Corporation Limited
Wiltrom Corporation Limited: FDA-registered device maker in Zhubei City Hsinchu(County), Taiwan, 2 510(k) clearances
Wiltrom Corporation Limited is registered with the FDA (registration 3011964577) in Zhubei City Hsinchu(County), Taiwan. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 23, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011964577
- Address
- 1 F., No. 26, Sec. 2, Shengyi Rd., Zhubei City Hsinchu(County), Taiwan, 30261
- Owner or operator
- Wiltrom Corporation Limited (10042632)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- February 9, 2018
- Registered through
- 2026
- Brand names listed
- Bicera Resorbable Bone Substitute, Wiltrom Orthopedic Manual Surgical Instrument, Wiltrom Spinal Fixation System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Filler, Bone Void, Calcium Compound | MQV | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Thoracolumbosacral Pedicle Screw System | NKB | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| October 23, 2020 | K202894 | Wiltrom Spinal Fixation System | NKB | Substantially Equivalent | Wiltrom Corporation Limited | accessdata.fda.gov |
| February 2, 2018 | K172237 | Bicera Resorbable Bone Substitute | MQV | Substantially Equivalent | Wiltrom Corporation Limited | accessdata.fda.gov |
Compare with other makers
- All makers of Filler, Bone Void, Calcium Compound
- All makers of Thoracolumbosacral Pedicle Screw System
- All makers of Orthopedic Manual Surgical Instrument
Updated October 23, 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.