MODEL 8000 ATLAS C-1 ORTHOGONAL ADJUSTING INSTRUMENT

Manipulator, Plunger-like Joint

SPINALIGHT, INC.

The following data is part of a premarket notification filed by Spinalight, Inc. with the FDA for Model 8000 Atlas C-1 Orthogonal Adjusting Instrument.

Pre-market Notification Details

Device IDK946258
510k NumberK946258
Device Name:MODEL 8000 ATLAS C-1 ORTHOGONAL ADJUSTING INSTRUMENT
ClassificationManipulator, Plunger-like Joint
Applicant SPINALIGHT, INC. 320-A BELL PARK DR. Woodstock,  GA  30188 -1661
ContactT A Cox
CorrespondentT A Cox
SPINALIGHT, INC. 320-A BELL PARK DR. Woodstock,  GA  30188 -1661
Product CodeLXM  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-12-06
Decision Date1995-11-20

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