Data / Medical devices / United States / Wiltrom Inc.
Wiltrom Inc.: FDA-registered device maker in San Jose, CA, United States, 2 510(k) clearances
Wiltrom Inc. is registered with the FDA (registration 3014387294) in San Jose, CA, United States. 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
- 3014387294
- Address
- 2880 Zanker Road, Suite 103, San Jose, CA, United States, 95134
- Owner or operator
- Wiltrom Inc. (10059962)
- Roles
- Complaint file establishment
- First device listed
- March 14, 2019
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Filler, Bone Void, Calcium Compound | MQV | 2 | Complaint file establishment | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Complaint file establishment | accessdata.fda.gov |
| Thoracolumbosacral Pedicle Screw System | NKB | 2 | Complaint file establishment | 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 Orthopedic Manual Surgical Instrument
- All makers of Thoracolumbosacral Pedicle Screw System
- All makers of Filler, Bone Void, Calcium Compound
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.