Data / Medical devices / United States / HyperFlex Medical Inc
HyperFlex Medical Inc: FDA-registered device maker in Richmond, UT, United States, 2 510(k) clearances
HyperFlex Medical Inc is registered with the FDA (registration 3038503572) in Richmond, UT, United States. It lists 5 device types. The FDA files 2 510(k) clearances under its listings, the newest dated December 11, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3038503572
- Address
- 253 South 200 West STE 1, Richmond, UT, United States, 84333
- Owner or operator
- HyperFlex Medical Inc. (10093440)
- Roles
- Repackager or relabeler, Specification developer
- First device listed
- May 15, 2025
- Registered through
- 2026
- Brand names listed
- HyperFlex Bunion Correction System, HyperFlex Reduction Clamp
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Instrument, Compression | HWN | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Plate, Fixation, Bone | HRS | 2 | 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 |
|---|---|---|---|---|---|---|
| December 11, 2025 | K252997 | HyperFlex® Bunion Correction System | HRS | Substantially Equivalent | Hyperflex Medical | accessdata.fda.gov |
| November 26, 2024 | K241995 | HyperFlex Bunion Correction System | HRS | Substantially Equivalent | Footbridge Medical | accessdata.fda.gov |
Compare with other makers
- All makers of Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
- All makers of Instrument, Compression
- All makers of Screw, Fixation, Bone
- All makers of Plate, Fixation, Bone
- All makers of Orthopedic Manual Surgical Instrument
Updated December 11, 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.