Data / Medical devices / United States / Ingeniumspine, LLC
Ingeniumspine, LLC: FDA-registered device maker in Tempe, AZ, United States, 2 510(k) clearances
Ingeniumspine, LLC is registered with the FDA (registration 3014268622) in Tempe, AZ, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 4, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014268622
- Address
- 1255 W Rio Salado Parkway #107, Tempe, AZ, United States, 85281
- Owner or operator
- IngeniumSpine, LLC (10056906)
- Roles
- Specification developer
- First device listed
- January 29, 2018
- Registered through
- 2026
- Brand names listed
- INGENIX
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Appliance, Fixation, Spinal Interlaminal | KWP | 2 | Specification developer | accessdata.fda.gov |
| Thoracolumbosacral Pedicle Screw System | NKB | 2 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| June 4, 2024 | K241258 | Ingenix Spinal System | NKB | Substantially Equivalent | Ingenium Spine | accessdata.fda.gov |
| December 5, 2017 | K173126 | Arisstos Spinal System | NKB | Substantially Equivalent | Ingenium Spine | accessdata.fda.gov |
Compare with other makers
- All makers of Thoracolumbosacral Pedicle Screw System
- All makers of Appliance, Fixation, Spinal Interlaminal
Updated June 4, 2024. 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.