Data / Medical devices / United States / Spinal Alignment Solutions
Spinal Alignment Solutions: FDA-registered device maker in Wilmington, NC, United States, 1 510(k) clearance
Spinal Alignment Solutions is registered with the FDA (registration 3038505140) in Wilmington, NC, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 28, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3038505140
- Address
- 8044 Market Street Suite A, Wilmington, NC, United States, 28411
- Owner or operator
- Spinal Alignment Solutions (10093471)
- Roles
- Specification developer
- First device listed
- May 21, 2025
- Registered through
- 2026
- Brand names listed
- SAS PI-Rod, Spinal Alignment Solutions Pelvic Incidence (PI) Rod System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Thoracolumbosacral Pedicle Screw System | NKB | 2 | Specification developer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | 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 |
|---|---|---|---|---|---|---|
| October 28, 2024 | K242350 | Spinal Alignment Solutions Pelvic Incidence (PI) Rod System | NKB | Substantially Equivalent | Spinal Alignment Solutions, Inc. | accessdata.fda.gov |
Compare with other makers
Updated October 28, 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.