FDA Registration
Active
🇺🇸 United States
SpineJet 30 degree XL MIS Fusion Handpiece
Reg #: 1226424
·
FEI: 3003018854
·
Expires 2025
Products
1
Proprietary Names
9
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- HYDROCISION, INC.
- Registration Number
- 1226424
- FEI Number
- 3003018854
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 267 Boston Road, Suite 28
- City
- BILLERICA
- State
- MA
- ZIP
- 01862
- Country
- US
Regulatory Submissions
- 510(k) Number
- K200729
Owner / Operator
- Firm Name
- HYDROCISION, INC.
- Operator Number
- 9041017
- Address
- 267 Boston Road, Suite 28
- City
- North Billerica
- State
- MA
- Postal Code
- 01862
- Country
- US
- Correspondent
- Mark J Lewis
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2020-04-24 |
Proprietary Names
SpineJet 30 degree XL MIS Fusion Handpiece
SpineJet MicroResector Discectomy Handpiece
SpineJet EndoResector Discectomy Handpiece
SpineJet 75 degree XLS Fusion Handpiece
SpineJet 20 degree XLS Fusion Handpiece
SpineJet 20 degree XL MIS Fusion Handpiece
SpineJet PercResector Discectomy Handpiece
SpineJet 20 degree XLE Fusion Handpiece
SpineJet 10 degree DL (pull) Fusion Handpiece
Establishment Types
Manufacture Medical Device