DISCOGRAPHY KIT

System, X-ray, Photofluorographic

SPINAL SPECIALTIES, INC.

The following data is part of a premarket notification filed by Spinal Specialties, Inc. with the FDA for Discography Kit.

Pre-market Notification Details

Device IDK960082
510k NumberK960082
Device Name:DISCOGRAPHY KIT
ClassificationSystem, X-ray, Photofluorographic
Applicant SPINAL SPECIALTIES, INC. 4230 CENTERGATE San Antonio,  TX  78217
ContactMichael Wakely
CorrespondentMichael Wakely
SPINAL SPECIALTIES, INC. 4230 CENTERGATE San Antonio,  TX  78217
Product CodeIZG  
CFR Regulation Number892.1730 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-01-11
Decision Date1996-03-21

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10381780262831 K960082 000
10381780262824 K960082 000
10381780261247 K960082 000

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