FDA Registration
Active
🇺🇸 United States
KEOS
Reg #: 3013921069
·
FEI: 3013921069
·
Expires 2026
Products
4
Proprietary Names
4
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- KEOS
- Registration Number
- 3013921069
- FEI Number
- 3013921069
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1824 COLONIAL VILLAGE LN
- City
- Lancaster
- State
- PA
- ZIP
- 17601
- Country
- US
Regulatory Submissions
- 510(k) Number
- K160631
Owner / Operator
- Firm Name
- Keos
- Operator Number
- 10055802
- Address
- 1824 Colonial Village Lane
- City
- Lancaster
- State
- PA
- Postal Code
- 17601
- Country
- US
- Correspondent
- Scott Peterson
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2018-12-06 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2017-10-09 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2017-10-08 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2023-12-13 |
Proprietary Names
General Instrument
Keos IBFD Tray
Keos Lumbar IBFD
Keos Anterior Cervical IBFD
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility