FDA Registration
Active
🇺🇸 United States
Tyber Medical Ø2.5 HCS
Reg #: 3017980495
·
FEI: 3017980495
·
Expires 2025
Products
1
Proprietary Names
14
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
- K133842
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 |
|---|---|---|---|---|---|
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2014-04-09 |
Proprietary Names
Tyber Medical Ø2.5 HCS
Tyber Medical Ø5 HCS
Tyber Medical Ø4 HCS
Tyber Medical Ø4.5 HCS
Tyber Medical Ø6.5 HCS
Tyber Medical Ø6 HCS
Tyber Medical Ø8 HCS
Tyber Medical Ø3 HCS
Tyber Medical Ø9 HCS
Tyber Medical Ø3.5 HCS
Tyber Medical Ø7 HCS
Tyber Medical Ø2 HCS
Tyber Medical Ø5.5 HCS
Tyber Medical Ø1.5 HCS
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198