Data / Medical devices / United Kingdom / XL Precision Technologies Ltd
XL Precision Technologies Ltd: FDA-registered device maker in Stockton on Tees Stockton-on-Tees, United Kingdom, 1 510(k) clearance
XL Precision Technologies Ltd is registered with the FDA (registration 3008034554) in Stockton on Tees Stockton-on-Tees, United Kingdom. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 19, 2014. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008034554
- Address
- 79 Sadler Forster Way, Stockton on Tees Stockton-on-Tees, United Kingdom, TS17 9JY
- Owner or operator
- XL Precision Technologies Ltd (10060853)
- Roles
- Contract manufacturer, Exporter to the US
- First device listed
- July 3, 2019
- Registered through
- 2026
- Brand names listed
- Hydrodam Re-usable Obturator Handle, Hydrodam Re-usable Obturator Shaft 5mm, Hydrodam Re-usable Obturator Shaft 7mm, Hydrodam Re-usable Obturator Shaft 8.5mm, Quick-Start, ToggleLoc 2.9 and JuggerLoc Soft Tissue System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cannula, Surgical, General & Plastic Surgery | GEA | 1 | Contract manufacturer, Exporter to the US | accessdata.fda.gov |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | 2 | Contract manufacturer, Exporter to the US | accessdata.fda.gov |
| Screw, Fixation, Bone | HWC | 2 | Contract manufacturer | accessdata.fda.gov |
| Staple, Fixation, Bone | JDR | 2 | Contract manufacturer, Exporter to the US | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 19, 2014 | K141263 | TOGGLELOC AND JUGGERLOC IMPLANTS/INSTRUMENTS/KITS | JDR | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
Compare with other makers
- All makers of Staple, Fixation, Bone
- All makers of Fastener, Fixation, Nondegradable, Soft Tissue
- All makers of Screw, Fixation, Bone
- All makers of Cannula, Surgical, General & Plastic Surgery
Updated November 19, 2014. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.