Data / Medical devices / United States / Astra Orthomed, Inc.
Astra Orthomed, Inc.: FDA-registered device maker in Woodstock, GA, United States, 1 510(k) clearance
Astra Orthomed, Inc. is registered with the FDA (registration 3041501961) in Woodstock, GA, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 27, 2025. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3041501961
- Address
- 7842 Hickory Flat Hwy, Woodstock, GA, United States, 30188
- Owner or operator
- Astra OrthoMed, Inc. (10094256)
- Roles
- Specification developer
- First device listed
- November 20, 2025
- Registered through
- 2026
- Brand names listed
- Orthopedic Manual Surgical Instruments - Phoenix Sinus Tarsi Stent System, Phoenix Sinus Tarsi Stent System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Orthopedic Manual Surgical Instrument | LXH | 1 | Specification developer | accessdata.fda.gov |
| Screw, Fixation, Bone | HWC | 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 |
|---|---|---|---|---|---|---|
| August 27, 2025 | K251382 | Phoenix Sinus Tarsi Stent System | HWC | Substantially Equivalent | Astra Orthomed, Inc. | accessdata.fda.gov |
Compare with other makers
Updated August 27, 2025. 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.