Data / Medical devices / United Kingdom / Naitive Technologies Ltd
Naitive Technologies Ltd: FDA-registered device maker in Cambridge Cambridgeshire, United Kingdom, 1 510(k) clearance
Naitive Technologies Ltd is registered with the FDA (registration 3041277558) in Cambridge Cambridgeshire, United Kingdom. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated September 2, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3041277558
- Address
- c/o Mishcon de Reya Four Station Square, Cambridge Cambridgeshire, United Kingdom, CB1 2GE
- Owner or operator
- Naitive Technologies Ltd (10093413)
- Roles
- Manufacturer
- First device listed
- September 4, 2025
- Registered through
- 2027
- Brand names listed
- OsteoSight
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density | SAO | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| September 2, 2025 | K251408 | OsteoSight Hip (v1) | SAO | Substantially Equivalent | Naitive Technologies, Ltd. | accessdata.fda.gov |
Updated September 2, 2025. 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.