FDA Registration
Active
🇺🇸 United States
TENON MEDICAL, INC.
Reg #: 3015425107
·
FEI: 3015425107
·
Expires 2026
Products
1
Proprietary Names
3
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- TENON MEDICAL, INC.
- Registration Number
- 3015425107
- FEI Number
- 3015425107
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 104 Cooper Court
- City
- Los Gatos
- State
- CA
- ZIP
- 95032
- Country
- US
Regulatory Submissions
- 510(k) Number
- K151818
Owner / Operator
- Firm Name
- Tenon Medical, Inc.
- Operator Number
- 10059873
- Address
- 104 Cooper Court
- City
- Los Gatos
- State
- CA
- Postal Code
- 95032
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Sacroiliac Joint Fixation | OUR | Class 2 | Orthopedic | No | 2025-12-31 |
Proprietary Names
SImmetry SI Joint Fusion System
Catamaran Sacroiliac Joint System (CAT SIJ Joint System)
SImmetry+ SI Joint Fusion System
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198