FDA Registration
Active
🇬🇧 United Kingdom
IMPLANTS INTL. LTD.
Reg #: 1000547811
·
FEI: 1000547811
·
Expires 2026
Products
10
Proprietary Names
11
Establishment Types
2
Classifications
10
Registration Details
- Registration Name
- IMPLANTS INTL. LTD.
- Registration Number
- 1000547811
- FEI Number
- 1000547811
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 71 JAY AVE., TEESSIDE INDUSTRIAL EST.
- City
- THORNABY-ON-TEES Stockton-on-Tees
- Country
- GB
Regulatory Submissions
- 510(k) Number
- K990307
Owner / Operator
- Firm Name
- IMPLANTS INTL. LTD.
- Operator Number
- 9046526
- Address
- 71 JAY AVE., TEESSIDE INDUSTRIAL EST.
- City
- THORNABY-ON-TEES
- State
- GB-NOTA
- Postal Code
- T517 9LZ
- Country
- GB
US Agent
- Business Name
- Xtremity Solutions, Inc.
- Contact Name
- George Cipolletti
- Address
- 20 Baileys Circle
- City
- Duxbury
- State
- MA
- ZIP
- 02331
- Country
- US
- [email protected]
- Phone
- 508 5746038
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Appliance, Fixation, Nail/Blade/Plate Combination, Single Component | KTW | Class 2 | Orthopedic | No | 2008-01-05 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2008-01-05 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2008-01-05 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | Class 2 | Orthopedic | No | 2008-01-05 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2008-01-05 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | LWJ | Class 2 | Orthopedic | No | 2008-01-05 |
| Prosthesis, Wrist, 2 Part Metal-Plastic Articulation, Semi-Constrained | JWI | Class 2 | Orthopedic | No | 2008-01-05 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2014-12-29 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2001-06-13 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2008-01-05 |
Proprietary Names
Omni-Fix Femoral and Tibial Nail
Omni-Fix IM Humeral Nail
CL Stem Stability Hip
Regi-Fix Hip
Rim-Fix Cup
Performa C-Fit Hip
Cer-Met III Cup
Universal Wrist Implant System
Ring-Lok BI-POLAR
Peri-articular Forceps
SLK Evo. Cemented Knee (St. Leger)
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)