FDA Registration
Active
🇬🇧 United Kingdom
XIROS LTD
Reg #: 8044102
·
FEI: 3013299874
·
Expires 2026
Products
13
Proprietary Names
42
Establishment Types
2
Classifications
13
Registration Details
- Registration Name
- XIROS LTD
- Registration Number
- 8044102
- FEI Number
- 3013299874
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- SPRINGFIELD HOUSE, WHITEHOUSE LANE
- City
- YEADON Leeds
- Country
- GB
Regulatory Submissions
- 510(k) Number
- K151601
Owner / Operator
- Firm Name
- XIROS LTD
- Operator Number
- 9001185
- Address
- SPRINGFIELD HOUSE, WHITEHOUSE LANE
- City
- YEADON
- State
- Leeds
- Postal Code
- LS19 7UE
- Country
- GB
- Correspondent
- Derrick White
US Agent
- Business Name
- KEC Consulting
- Contact Name
- Ken Carrier
- Address
- 47 Cordis Street
- City
- Wakefield
- State
- MA
- ZIP
- 01880
- Country
- US
- [email protected]
- Phone
- 781 2465220
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Extractor | HWB | Class 1 | Orthopedic | No | 2004-08-12 |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2015-10-09 |
| Staple, Fixation, Bone | JDR | Class 2 | Orthopedic | No | 2008-01-18 |
| Mesh, Surgical, Polymeric | FTL | Class 2 | General, Plastic Surgery | No | 2022-09-28 |
| Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon | OWX | Class 2 | General, Plastic Surgery | No | 2022-09-28 |
| Staple Driver | HXJ | Class 1 | Orthopedic | No | 2004-08-12 |
| Mesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament | QUW | Class 2 | General, Plastic Surgery | No | 2025-08-14 |
| Passer | HWQ | Class 1 | Orthopedic | No | 2019-09-24 |
| Probe | HXB | Class 1 | Orthopedic | No | 2022-09-01 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2019-05-16 |
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | Class 2 | General, Plastic Surgery | No | 2019-12-19 |
| Orthopedic Tray | OJH | Class 1 | General, Plastic Surgery | No | 2025-09-04 |
| Hook, Surgical, General & Plastic Surgery | GDG | Class 1 | General, Plastic Surgery | No | 2015-10-09 |
Proprietary Names
sliding hammer
SECURE LOOP 102-4015
SECURE LOOP 102-4035
SECURE LOOP 102-4010
SECURE LOOP 102-4025
SECURE LOOP 102-4045
SECURE LOOP 102-4040
SECURE LOOP 102-4060
SECURE LOOP 102-4020
SECURE LOOP 102-4050
SECURE LOOP 102-4030
SECURE LOOP 102-4055
Poly-Tape, 30 mm x 800 mm (open weave). 102-1083
102-1102 Infinity-Lock 7 mm x 400 mm
102-1100 Infinity-Lock 3 mm x 400 mm
102-1082 Poly-Tape 20 mm x 800 mm
102-1101 Infinity-Lock 5 mm x 400 mm
102-1087 Poly-Tape 7 mm x 800 mm
102-1080 Poly-Tape 10 mm x 800 mm
102-1086 Poly-Tape 5 mm x 800 mm
102-1081 Poly-Tape 15 mm x 800 mm
Impactor Assembly. 202-1137
Pitch Patch Tissue Reinforcement 30mm x 20mm. 102-1090
Pitch Patch Tissue Reinforcement 35mm x 25mm. 102-1091
TekBrace Solo, 25cm, 2470S025
TekBrace Solo, 12cm, 2470S012
FlexPasser Tendon Retrieval Kit. 202-1500
Malleable Probe
Rigid Probe
102-1143 AchilloCordPLUS
10050 SIC Graft
MWEB5040 FORCEWEB 5 mm x 500 mm
102-1005 Poly-Tape 5 mm x 500 mm
102-1083 Poly-Tape 30 mm x 800 mm
Infinity-Lock Button System
Infinity-Lock 5. 102-1101
Infinity-Lock 3. 102-1100
Fastlok 6x23mm. 102-1380
Fastlok 8x23mm. 102-1381
FORCECORD
CC-Hook, Left. 202-1411
CC-Hook, Right. 202-1413
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)