FDA Registration
Active
🇺🇸 United States
iNSitu Total Hip System
Reg #: 3002498892
·
FEI: 3002498892
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- THEKEN COMPANIES, LLC
- Registration Number
- 3002498892
- FEI Number
- 3002498892
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1800 Triplett Blvd
- City
- Akron
- State
- OH
- ZIP
- 44306
- Country
- US
Regulatory Submissions
- 510(k) Number
- K161184
Owner / Operator
- Firm Name
- Theken Companies, LLC
- Operator Number
- 10050903
- Address
- 1800 Triplett Blvd
- City
- Akron
- State
- OH
- Postal Code
- 44306
- Country
- US
- Correspondent
- Garrett Spurgeon
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | OQG | Class 2 | Orthopedic | No | 2016-11-09 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2016-11-09 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2016-11-09 |
| Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented | OQI | Class 2 | Orthopedic | No | 2016-11-09 |
Proprietary Names
iNSitu Total Hip System
Establishment Types
Manufacture Medical Device