FDA Registration
Active
🇬🇧 United Kingdom
AXIS SPINE TECHNOLOGIES LTD
Reg #: 3016668776
·
FEI: 3016668776
·
Expires 2026
Products
1
Proprietary Names
1
Establishment Types
6
Classifications
1
Registration Details
- Registration Name
- AXIS SPINE TECHNOLOGIES LTD
- Registration Number
- 3016668776
- FEI Number
- 3016668776
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Century Offices, 2175 Century Way, Thorpe Park
- City
- Leeds
- Country
- GB
Regulatory Submissions
- 510(k) Number
- K210590
Owner / Operator
- Firm Name
- Axis Spine Technologies Ltd
- Operator Number
- 10078787
- Address
- Century Offices, 2175 Century Way, Thorpe Park
- City
- Leeds
- State
- GB-NOTA
- Postal Code
- LS15 8ZB
- Country
- GB
- Correspondent
- James Hewitt
US Agent
- Business Name
- Applied Technical Services
- Contact Name
- Hannah Taggart
- Address
- 4628 Northpark Dr
- City
- Colorado Springs
- State
- CO
- ZIP
- 80918
- Country
- US
- [email protected]
- Phone
- 719 4571152
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2021-12-22 |
Proprietary Names
AXIS ALIF IMPLANTS
Establishment Types
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device
Reprocess Single-Use Device
Complaint File Establishment per 21 CFR 820.198
Remanufacture Medical Device