FDA Registration
Active
🇺🇸 United States
TECHFIT Patient-Specific Maxillofacial System
Reg #: 3016560308
·
FEI: 3016560308
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- TECHFIT DIGITAL SURGERY INC
- Registration Number
- 3016560308
- FEI Number
- 3016560308
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 1511 Aviation Center Pkwy Suite 220H Daytona Beach, FL 32114
- City
- Daytona Beach
- State
- FL
- ZIP
- 32114
- Country
- US
Regulatory Submissions
- 510(k) Number
- K203282
Owner / Operator
- Firm Name
- TECHFIT DIGITAL SURGERY INC
- Operator Number
- 10062668
- Address
- 1511 Aviation Center Pkwy Suite 220H Daytona Beach, FL 32114
- City
- Daytona Beach
- State
- FL
- Postal Code
- 32114
- Country
- US
- Correspondent
- Laura Buitrago
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Plate, Bone | JEY | Class 2 | Dental | No | 2021-07-02 |
Proprietary Names
TECHFIT Patient-Specific Maxillofacial System
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device