FDA Registration
Active
🇺🇸 United States
Ogmend Implant Enhancement System
Reg #: 3017505709
·
FEI: 3017505709
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- WOVEN ORTHOPEDIC TECHNOLOGIES
- Registration Number
- 3017505709
- FEI Number
- 3017505709
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 750 E Main St Ste 620
- City
- Stamford
- State
- CT
- ZIP
- 06902
- Country
- US
Regulatory Submissions
- 510(k) Number
- K233223
Owner / Operator
- Firm Name
- Woven Orthopedic Technologies
- Operator Number
- 10081391
- Address
- 750 East Main Street Ste 620
- City
- Stamford
- State
- CT
- Postal Code
- 06902
- Country
- US
- Correspondent
- Stephen M Page
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Screw Sleeve Bone Fixation Device, Spine | QVI | Class 2 | Orthopedic | No | 2024-08-21 |
Proprietary Names
Ogmend Implant Enhancement System
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198