FDA Registration
Active
🇺🇸 United States
Modular Pedicle Screw (MPS) System
Reg #: 3016496998
·
FEI: 3016496998
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- TESLAKE, INC.
- Registration Number
- 3016496998
- FEI Number
- 3016496998
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 17150 Via Del Campo, Suite 308
- City
- San Diego
- State
- CA
- ZIP
- 92127
- Country
- US
Regulatory Submissions
- 510(k) Number
- K240963
Owner / Operator
- Firm Name
- Teslake, Inc.
- Operator Number
- 10062341
- Address
- 7 Beechbrook Lane
- City
- Rochester
- State
- NY
- Postal Code
- 14625
- Country
- US
- Correspondent
- Lukas Eisermann
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2025-01-30 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2025-01-30 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2025-01-30 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2025-01-30 |
Proprietary Names
Modular Pedicle Screw (MPS) System
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility