Data / Medical devices / United States / Mainstay Medical (MML US, Inc.)
Mainstay Medical (MML US, Inc.): FDA-registered device maker in San Diego, CA, United States, 1 PMA approval
Mainstay Medical (MML US, Inc.) is registered with the FDA (registration 3021520203) in San Diego, CA, United States. It lists 2 device types. The FDA files 1 PMA approval under its listings, the newest dated June 16, 2020. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3021520203
- Address
- 2159 India Street, San Diego, CA, United States, 92101
- Owner or operator
- Mainstay Medical Limited (10076126)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- July 8, 2020
- Registered through
- 2027
- Brand names listed
- ReActiv8, ReActiv8 Release Tool
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Orthopedic Manual Surgical Instrument | LXH | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Stimulator, Neuromuscular, Lower Back Muscles, Totally Implanted For Pain Relief | QLK | 3 | Complaint file establishment, Specification developer | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| June 16, 2020 | P190021 | ReActiv8 Implantable Neurostimulation System | QLK | 8 | October 19, 2026 | accessdata.fda.gov |
Compare with other makers
- All makers of Stimulator, Neuromuscular, Lower Back Muscles, Totally Implanted For Pain Relief
- All makers of Orthopedic Manual Surgical Instrument
Updated October 19, 2026. 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.