Spinalight Inc
St Petersburg, FL, US
SPINALIGHT INC appears in FDA device records in St Petersburg, FL. FDA records list 7 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Spinalight Inc carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Advanced Orthogonal Equipment, Incorporatedenforcement report, recall
510(k) clearance history
FDA records hold 7 510(k) clearances for Spinalight Inc between 1994 and 2018. The busiest year on record is 1994, with 2. The most recent is 2018, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1994 | 2 |
| 1995 | 2 |
| 1996 | 1 |
| 2000 | 1 |
| 2018 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K172536 | Atlas Percussion Adjusting Instrument | LXM | Substantially Equivalent | |
| K001476 | TORQUE INSTRUMENT, MODEL 8500 | LXM | Substantially Equivalent | |
| K955540 | HAND HELD ATLAS INSTRUMENT | LXM | Substantially Equivalent | |
| K946258 | MODEL 8000 ATLAS C-1 ORTHOGONAL ADJUSTING INSTRUMENT | LXM | Substantially Equivalent | |
| K945954 | MODELS 4100 AND 4300 MULTITHERAPY | JFB | Substantially Equivalent | |
| K933622 | FLEXION DISTRACTION TABLE | INQ | Substantially Equivalent | |
| K933621 | HILO TABLE | INQ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3006315109 | 3006315109 | SPINALIGHT INC | 2201 62ND AVENUE NORTH, St Petersburg, FL 33702 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1809-2013 | 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 | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain
