Data / Medical devices / United States / Spinalight Inc
Spinalight Inc: FDA-registered device maker in St Petersburg, FL, United States, 1 510(k) clearance
Spinalight Inc is registered with the FDA (registration 3006315109) in St Petersburg, FL, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated June 20, 2018. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006315109
- Address
- 2201 62ND Avenue North, St Petersburg, FL, United States, 33702
- Owner or operator
- Spinalight Inc (9102583)
- Roles
- Manufacturer
- First device listed
- October 27, 2022
- Registered through
- 2026
- Brand names listed
- Atlas Percussion Adjusting Instrument
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Manipulator, Plunger-Like Joint | LXM | U | 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 |
|---|---|---|---|---|---|---|
| June 20, 2018 | K172536 | Atlas Percussion Adjusting Instrument | LXM | Substantially Equivalent | Spinalight, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| March 6, 2013 | 65391 | Class II | Terminated | Advanced Orthogonal Percussion Adjusting Instrument Indicated for use by a licensed Chiropractor to assist in making Chiropractic adjustments to the Atlas vertebra. | Unapproved medical device | accessdata.fda.gov |
Compare with other makers
Updated June 20, 2018. 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.