HAND HELD ATLAS INSTRUMENT

Manipulator, Plunger-like Joint

SPINALIGHT, INC.

The following data is part of a premarket notification filed by Spinalight, Inc. with the FDA for Hand Held Atlas Instrument.

Pre-market Notification Details

Device IDK955540
510k NumberK955540
Device Name:HAND HELD ATLAS INSTRUMENT
ClassificationManipulator, Plunger-like Joint
Applicant SPINALIGHT, INC. 320 A BELL PARK DR. Woodstock,  GA  30188
ContactT. A. Cox
CorrespondentT. A. Cox
SPINALIGHT, INC. 320 A BELL PARK DR. Woodstock,  GA  30188
Product CodeLXM  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-12-05
Decision Date1996-03-04

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