Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR

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

510(k) clearances
7
PMA records
0
Recall records
1
Registered establishments
1

FDA records under these names

1 name

FDA 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
510(k) clearance decisions for Spinalight Inc, by decision year
YearClearances
19942
19952
19961
20001
20181
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K172536Atlas Percussion Adjusting InstrumentLXMSubstantially Equivalent
K001476TORQUE INSTRUMENT, MODEL 8500LXMSubstantially Equivalent
K955540HAND HELD ATLAS INSTRUMENTLXMSubstantially Equivalent
K946258MODEL 8000 ATLAS C-1 ORTHOGONAL ADJUSTING INSTRUMENTLXMSubstantially Equivalent
K945954MODELS 4100 AND 4300 MULTITHERAPYJFBSubstantially Equivalent
K933622FLEXION DISTRACTION TABLEINQSubstantially Equivalent
K933621HILO TABLEINQSubstantially Equivalent

Registered establishments

FDA registered establishments for Spinalight Inc, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30063151093006315109SPINALIGHT INC2201 62ND AVENUE NORTH, St Petersburg, FL 33702 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-1809-2013Advanced Orthogonal Percussion Adjusting Instrument Indicated for use by a licensed Chiropractor to assist in making Chiropractic adjustments to the Atlas vertebra.Unapproved medical deviceClass IITerminated

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.

What MDM checks, and what it does not

MDM coverage

MDM coverage of this company lists here, newest first. Submit news.

Is this your company?

This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.

Claiming lets Spinalight Inc edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.

Claim this page

Data as of , FDA export datePage updated Source: openFDA, public domain