Data / Medical devices / United States / Spinal Resources Inc
Spinal Resources Inc: FDA-registered device maker in Fort Lauderdale, FL, United States, 3 510(k) clearances
Spinal Resources Inc is registered with the FDA (registration 3012770122) in Fort Lauderdale, FL, United States. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated March 23, 2023. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3012770122
- Address
- 5975 North Federal Highway Suite 250, Fort Lauderdale, FL, United States, 33308
- Owner or operator
- Spinal Resources Inc (10054229)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- February 24, 2017
- Registered through
- 2026
- Brand names listed
- S Wire, Swedge Pedicle Screw System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Pin, Fixation, Smooth | HTY | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Pin, Fixation, Threaded | JDW | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Thoracolumbosacral Pedicle Screw System | NKB | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| March 23, 2023 | K230482 | Swedge Pedicle Screw Fixation System | NKB | Substantially Equivalent | Spinal Resources, Inc. | accessdata.fda.gov |
| June 26, 2017 | K170045 | Swedge Pedicle Screw Fixation System | NKB | Substantially Equivalent | Spinal Resources, Inc. | accessdata.fda.gov |
| March 9, 2016 | K152662 | S-Wire | HTY | Substantially Equivalent | Spinal Resources, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Thoracolumbosacral Pedicle Screw System
- All makers of Pin, Fixation, Smooth
- All makers of Pin, Fixation, Threaded
Updated March 23, 2023. 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.