FDA Registration
Active
🇬🇧 United Kingdom
XL PRECISION TECHNOLOGIES LTD
Reg #: 3008034554
·
FEI: 3008034554
·
Expires 2026
Products
4
Proprietary Names
6
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- XL PRECISION TECHNOLOGIES LTD
- Registration Number
- 3008034554
- FEI Number
- 3008034554
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 79 Sadler Forster Way
- City
- Stockton on Tees Stockton-on-Tees
- Country
- GB
Regulatory Submissions
- 510(k) Number
- K141263
Owner / Operator
- Firm Name
- XL Precision Technologies Ltd
- Operator Number
- 10060853
- Address
- 79 Sadler Forster Way
- City
- Stockton on Tees
- State
- Stockton-on-Tees
- Postal Code
- TS17 9JY
- Country
- GB
- Correspondent
- Laura Robinson
US Agent
- Business Name
- Spectra Medical Devices, LLC
- Contact Name
- Kavetha Ram
- Address
- 299 Ballardvale St
- City
- Wilmington
- State
- MA
- ZIP
- 01887
- Country
- US
- [email protected]
- Phone
- 978 6570889
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 2019-07-03 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2022-06-22 |
| Staple, Fixation, Bone | JDR | Class 2 | Orthopedic | No | 2020-01-15 |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2020-01-15 |
Proprietary Names
Hydrodam Re-usable Obturator Shaft 5mm
Hydrodam Re-usable Obturator Shaft 8.5mm
Hydrodam Re-usable Obturator Handle
Hydrodam Re-usable Obturator Shaft 7mm
Quick-Start
ToggleLoc 2.9 and JuggerLoc Soft Tissue System
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device for Another Party (Contract Manufacturer)