FDA Registration
Active
🇺🇸 United States
THERAMICRO
Reg #: 3032412536
·
FEI: 3032412536
·
Expires 2026
Products
6
Proprietary Names
5
Establishment Types
2
Classifications
6
Registration Details
- Registration Name
- THERAMICRO
- Registration Number
- 3032412536
- FEI Number
- 3032412536
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 51 Germantown Ct Ste 200
- City
- Cordova
- State
- TN
- ZIP
- 38018
- Country
- US
Regulatory Submissions
- 510(k) Number
- K242311
Owner / Operator
- Firm Name
- Theramicro
- Operator Number
- 10093892
- Address
- 51 Germantown Court, Suite 200
- City
- Cordova
- State
- TN
- Postal Code
- 38018
- Country
- US
- Correspondent
- Christine Scifert
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2026-04-13 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2025-07-30 |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2026-04-13 |
| Mesh, Surgical, Polymeric | FTL | Class 2 | General, Plastic Surgery | No | 2025-07-30 |
| Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon | OWX | Class 2 | General, Plastic Surgery | No | 2025-07-30 |
| Mesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament | QUW | Class 2 | General, Plastic Surgery | No | 2025-07-30 |
Proprietary Names
TeKForce Knotless Syndesmosis Implant
TekBrace
TeKForce All Suture Anchor
TekBrace Solo Soft Tissue Reinforcement Device
TekBrace Kit
Establishment Types
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility