FDA Registration
Active
🇺🇸 United States
RETROPSOAS TECHNOLOGIES, LLC
Reg #: 3031284747
·
FEI: 3031284747
·
Expires 2026
Products
5
Proprietary Names
5
Establishment Types
2
Classifications
5
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Registration Details
- Registration Name
- RETROPSOAS TECHNOLOGIES, LLC
- Registration Number
- 3031284747
- FEI Number
- 3031284747
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 34 Countryside Lane
- City
- Frontenac
- State
- MO
- ZIP
- 63131
- Country
- US
Regulatory Submissions
- 510(k) Number
- K230853
Owner / Operator
- Firm Name
- Retropsoas Technologies, LLC
- Operator Number
- 10090791
- Address
- 34 Countryside Lane
- City
- Frontenac
- State
- MO
- Postal Code
- 63131
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tray, Surgical | LRP | Class 1 | General, Plastic Surgery | No | 2025-12-19 |
| Stimulator, Nerve | ETN | Class 2 | Ear, Nose, Throat | No | 2024-05-14 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2024-10-11 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2025-12-19 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2025-12-19 |
Proprietary Names
EARP Implant Caddy and Lid
EARP Nerve Cuff Electrode
EARP Interbody System
EARP Preparation and Insertion Instruments
EARP Instrument Tray and Lid
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility