FDA Registration
Active
🇺🇸 United States
Insight Surgery Houston
Reg #: 3027329005
·
FEI: 3027329005
·
Expires 2026
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- Insight Surgery Houston
- Registration Number
- 3027329005
- FEI Number
- 3027329005
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- TMC Innovation, 2450 Holcombe Blvd, Suite 1820
- City
- Houston
- State
- TX
- ZIP
- 77021
- Country
- US
Regulatory Submissions
- 510(k) Number
- K220366
Owner / Operator
- Firm Name
- 3D LifePrints UK
- Operator Number
- 10085716
- Address
- Nuffield Orthopaedic Centre, Old Rd
- City
- Oxford
- State
- Oxfordshire
- Postal Code
- OX3 7LD
- Country
- GB
- Correspondent
- Matt Gailer
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Driver, Wire, And Bone Drill, Manual | DZJ | Class 2 | Dental | No | 2023-02-08 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2023-02-08 |
| Orthopaedic Surgical Planning And Instrument Guides | PBF | Class 2 | Orthopedic | No | 2023-05-17 |
Proprietary Names
EmbedMed
Establishment Types
Manufacture Medical Device