FDA Registration
Active
🇺🇸 United States
Intelligent Surgery Knee
Reg #: 3030409224
·
FEI: 3030409224
·
Expires 2025
Products
3
Proprietary Names
2
Establishment Types
2
Classifications
3
Registration Details
- Registration Name
- ENHATCH, INC
- Registration Number
- 3030409224
- FEI Number
- 3030409224
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 226 Boulevard
- City
- Hasbrouck Heights
- State
- NJ
- ZIP
- 07604
- Country
- US
Regulatory Submissions
- 510(k) Number
- K230850
Owner / Operator
- Firm Name
- Enhatch, Inc
- Operator Number
- 10089831
- Address
- 411 State Route 117, Suite 500
- City
- Hasbrouck Heights
- State
- NJ
- Postal Code
- 07604
- Country
- US
- Correspondent
- Monica Williams
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Knee Arthroplasty Implantation System | OOG | Class 2 | Orthopedic | No | 2024-01-11 |
| Orthopaedic Surgical Planning And Instrument Guides | PBF | Class 2 | Orthopedic | No | 2024-01-11 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2024-01-11 |
Proprietary Names
Intelligent Surgery Knee
United Orthopedic Knee Patient Specific Instrumentation
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility