FDA Registration
Active
🇺🇸 United States
Wire System
Reg #: 3017980495
·
FEI: 3017980495
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- Tyber Medical
- Registration Number
- 3017980495
- FEI Number
- 3017980495
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 89 South Commerce Way, Suite 990
- City
- Bethlehem
- State
- PA
- ZIP
- 18017
- Country
- US
Regulatory Submissions
- 510(k) Number
- K231339
Owner / Operator
- Firm Name
- Tyber Medical LLC
- Operator Number
- 10046574
- Address
- 83 South Commerce Way, Suite 310
- City
- Bethlehem
- State
- PA
- Postal Code
- 18017
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2023-12-15 |
Proprietary Names
Wire System
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198