Data / Medical devices / United States / RMR ORTHO, Inc
RMR ORTHO, Inc: FDA-registered device maker in San Antonio, TX, United States, 2 510(k) clearances
RMR ORTHO, Inc is registered with the FDA (registration 3031160399) in San Antonio, TX, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated January 12, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3031160399
- Address
- 4600 Lockhill Selma Road Suite 107, San Antonio, TX, United States, 78249
- Owner or operator
- RMR Ortho, Inc. (10090810)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- May 16, 2024
- Registered through
- 2026
- Brand names listed
- A'TOMIC PULSE, ATOMIC Nitinol Fixation System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Staple, Fixation, Bone | JDR | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| January 12, 2024 | K232990 | ATOMIC Nitinol Fixation System | JDR | Substantially Equivalent | Rmr Ortho, LLC | accessdata.fda.gov |
| August 3, 2023 | K231458 | Extremity Staple | JDR | Substantially Equivalent | Restor3D | accessdata.fda.gov |
Compare with other makers
Updated January 12, 2024. 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.