FDA Registration
Active
🇺🇸 United States
SPINEJET SYSTEM
Reg #: 1226424
·
FEI: 3003018854
·
Expires 2025
Products
1
Proprietary Names
6
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
- K032529
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 | 2000-04-10 |
Proprietary Names
SPINEJET SYSTEM
SpineJet XL
SpineJet Micro 3.8
SpineJet HydroSurgery Console
SpineJet PercResector
SpineJet EndoResector
Establishment Types
Manufacture Medical Device