BACFIX SPINAL FIXATION SYSTEM

Appliance, Fixation, Spinal Interlaminal

SPINAL CONCEPTS, INC.

The following data is part of a premarket notification filed by Spinal Concepts, Inc. with the FDA for Bacfix Spinal Fixation System.

Pre-market Notification Details

Device IDK964404
510k NumberK964404
Device Name:BACFIX SPINAL FIXATION SYSTEM
ClassificationAppliance, Fixation, Spinal Interlaminal
Applicant SPINAL CONCEPTS, INC. 701 BRAZOS SUITE 500 Austin,  TX  78701
ContactErin Mcgurk
CorrespondentErin Mcgurk
SPINAL CONCEPTS, INC. 701 BRAZOS SUITE 500 Austin,  TX  78701
Product CodeKWP  
CFR Regulation Number888.3050 [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-11-04
Decision Date1997-03-26

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