FDA Registration
Active
🇺🇸 United States
TenoTrap (7mm x15mm Tenodesis Screw)
Reg #: 3011061237
·
FEI: 3011061237
·
Expires 2025
Products
1
Proprietary Names
5
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Dunamis Medical LLC
- Registration Number
- 3011061237
- FEI Number
- 3011061237
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 104 Camellia Ave, Suite B
- City
- Greenville
- State
- AL
- ZIP
- 36037
- Country
- US
Regulatory Submissions
- 510(k) Number
- K193245
Owner / Operator
- Firm Name
- Dunamis Medical LLC
- Operator Number
- 10047203
- Address
- 104 Camellia Ave, Suite B
- City
- Greenville
- State
- AL
- Postal Code
- 36037
- Country
- US
- Correspondent
- Prithviraj Chavan
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2023-08-03 |
Proprietary Names
TenoTrap (7mm x15mm Tenodesis Screw)
TensionTac 3 Knotless Anchor PEEK
TensionTac 3.5 Knotless Anchor PEEK
Dunamis PunchTac Suture Anchor (PEEK)
TenoTrap (7mm x12mm Tenodesis Screw)
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device