Data / Medical devices / United States / Retropsoas Technologies, LLC
Retropsoas Technologies, LLC: FDA-registered device maker in Frontenac, MO, United States, 4 510(k) clearances
Retropsoas Technologies, LLC is registered with the FDA (registration 3031284747) in Frontenac, MO, United States. It lists 5 device types. The FDA files 4 510(k) clearances under its listings, the newest dated October 7, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3031284747
- Address
- 34 Countryside Lane, Frontenac, MO, United States, 63131
- Owner or operator
- Retropsoas Technologies, LLC (10090791)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- May 14, 2024
- Registered through
- 2026
- Brand names listed
- EARP Implant Caddy and Lid, EARP Instrument Tray and Lid, EARP Interbody System, EARP Nerve Cuff Electrode, EARP Preparation and Insertion Instruments
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Stimulator, Nerve | ETN | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Tray, Surgical | LRP | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | 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 |
|---|---|---|---|---|---|---|
| October 7, 2024 | K242457 | EARP Interbody System | MAX | Substantially Equivalent | Retropsoas Technologies, LLC | accessdata.fda.gov |
| July 31, 2024 | K241917 | EARP Nerve Cuff Electrode | ETN | Substantially Equivalent | Retropsoas Technologies, LLC | accessdata.fda.gov |
| October 6, 2023 | K230853 | EARP Nerve Cuff Electrode | ETN | Substantially Equivalent | Nvision Biomedical Technologies, Inc. | accessdata.fda.gov |
| April 28, 2022 | K212477 | EARP Interbody System | MAX | Substantially Equivalent | Nvision Biomedical Technologies, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Tray, Surgical, Instrument
- All makers of Tray, Surgical
- All makers of Stimulator, Nerve
- All makers of Intervertebral Fusion Device With Bone Graft, Lumbar
- All makers of Orthopedic Manual Surgical Instrument
Updated October 7, 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.