Data / Medical devices / United States / Rhausler, Inc.
Rhausler, Inc.: FDA-registered device maker in Fremont, CA, United States, 3 510(k) clearances
Rhausler, Inc. is registered with the FDA (registration 3007210720) in Fremont, CA, United States. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated November 19, 2015. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007210720
- Address
- 39737 Paseo Padre Pkwy Ste D, Fremont, CA, United States, 94538
- Owner or operator
- RHAUSLER, INC. (10026684)
- Roles
- Specification developer
- First device listed
- August 11, 2008
- Registered through
- 2026
- Brand names listed
- Anterior Cervical Plate System, PLAGE
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | 2 | Specification developer | accessdata.fda.gov |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | 2 | Specification developer | accessdata.fda.gov |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | 2 | 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 |
|---|---|---|---|---|---|---|
| November 19, 2015 | K150455 | RT2 Trabeculite Titanium Cervical Cage System | ODP | Substantially Equivalent | Rhausler, Inc. | accessdata.fda.gov |
| November 29, 2011 | K111272 | RHAUSLER PLAGE ANTERIOR CERVICAL FUSION SYSTEM | OVE | Substantially Equivalent | Rhausler, Inc. | accessdata.fda.gov |
| February 7, 2005 | K042073 | OLSEN MEDICAL ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM | KWQ | Substantially Equivalent | Olsen Medical | accessdata.fda.gov |
Compare with other makers
- All makers of Appliance, Fixation, Spinal Intervertebral Body
- All makers of Intervertebral Fusion Device With Bone Graft, Cervical
- All makers of Intervertebral Fusion Device With Integrated Fixation, Cervical
Updated November 19, 2015. 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.