FDA Registration
Active
🇺🇸 United States
Altivate Anatomic Humeral Head Neck Adapter
Reg #: 3009241418
·
FEI: 3009241418
·
Expires 2025
Products
3
Proprietary Names
4
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- TURNCO TOOL & INSTRUMENT, INC.
- Registration Number
- 3009241418
- FEI Number
- 3009241418
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 5080 East State Highway 29
- City
- Georgetown
- State
- TX
- ZIP
- 78626
- Country
- US
Regulatory Submissions
- 510(k) Number
- K162024
Owner / Operator
- Firm Name
- Turnco Tool & Instrument, Inc.
- Operator Number
- 10042197
- Address
- 5080 East State Highway 29
- City
- Georgetown
- State
- TX
- Postal Code
- 78626
- Country
- US
- Correspondent
- Brandon Griffin
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2018-09-18 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented | PAO | Class 2 | Orthopedic | No | 2018-09-18 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2018-09-18 |
Proprietary Names
Altivate Anatomic Humeral Head Neck Adapter
Altivate Anatomic Drill Guide Handle
Altivate Anatomic Turon Humeral Head Neck Adapter
Altivate Anatomic Modular Head Trial
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)