FDA Registration
Active
🇺🇸 United States
SUTURE TECH, INC.
Reg #: 3043861298
·
FEI: 3043861298
·
Expires 2026
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- SUTURE TECH, INC.
- Registration Number
- 3043861298
- FEI Number
- 3043861298
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 810 Laurelwood Dr
- City
- Durham
- State
- NC
- ZIP
- 27705
- Country
- US
Regulatory Submissions
- 510(k) Number
- K250095
Owner / Operator
- Firm Name
- Suture Tech, Inc.
- Operator Number
- 10095388
- Address
- 810 Laurelwood Dr.
- City
- Durham
- State
- NC
- Postal Code
- 27705
- Country
- US
- Correspondent
- Okechukwu Anakwenze
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2026-03-06 |
Proprietary Names
RapidFix All-Suture Dual Anchor
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility