FDA Registration
Active
🇺🇸 United States
Screw, Femur, G2
Reg #: 3007137928
·
FEI: 3007137928
·
Expires 2025
Products
1
Proprietary Names
7
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Tecomet Boulder
- Registration Number
- 3007137928
- FEI Number
- 3007137928
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 6265 Gunbarrel Ave Suite A
- City
- Boulder
- State
- CO
- ZIP
- 80301
- Country
- US
Regulatory Submissions
- 510(k) Number
- K151364
Owner / Operator
- Firm Name
- Tecomet, Inc.
- Operator Number
- 10042631
- Address
- 170 New Boston Street
- City
- Woburn
- State
- MA
- Postal Code
- 01801
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2016-05-27 |
Proprietary Names
Screw, Femur, G2
Guide, Pelvic Screw, G2
Trocar, Pelvic Screw, G2
Screw, Pelvic, G2
Sleeve, Pelvic Screw, G2
Screw, Pelvic, G2, 136 MM
Screw, Spherical Head, Femoral, G2, 26 MM
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)