FDA.report

510(k) K964404

Device
BACFIX SPINAL FIXATION SYSTEM
Applicant
SPINAL CONCEPTS, INC.
510(k) number
K964404
Product code
KWP  
Decision
Substantially Equivalent For Some Indications (SN)
Decision date
1997-03-26
Date received
1996-11-04
Regulation
888.3050
Classification name
Appliance, Fixation, Spinal Interlaminal
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
ERIN MCGURK
Address
701 Brazos Suite 500 Austin TX US 78701 78701

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF not indicated by FDA · openFDA JSON

Legacy Summary

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FDA Review

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