FDA Registration
Active
🇺🇸 United States
OnPoint Augmented Reality Spine System
Reg #: 3016534677
·
FEI: 3016534677
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ONPOINT SURGICAL
- Registration Number
- 3016534677
- FEI Number
- 3016534677
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 555 Virginia Rd, Suite 103
- City
- Concord
- State
- MA
- ZIP
- 01742
- Country
- US
Regulatory Submissions
- 510(k) Number
- K231284
Owner / Operator
- Firm Name
- OnPoint Surgical
- Operator Number
- 10090623
- Address
- 555 Virginia Rd, Suite 103
- City
- Concord
- State
- MA
- Postal Code
- 01742
- Country
- US
- Correspondent
- Michael Manor
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2024-04-20 |
Proprietary Names
OnPoint Augmented Reality Spine System
Establishment Types
Manufacture Medical Device