Cleared Traditional

DISCOGRAPHY KIT

K960082 · Spinal Specialties, Inc. · Radiology
Mar 1996
Decision
70d
Days
Class 2
Risk

About This 510(k) Submission

K960082 is an FDA 510(k) clearance for the DISCOGRAPHY KIT, a System, X-ray, Photofluorographic (Class II — Special Controls, product code IZG), submitted by Spinal Specialties, Inc. (San Antonio, US). The FDA issued a Cleared decision on March 21, 1996, 70 days after receiving the submission on January 11, 1996. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1730.

Submission Details

510(k) Number K960082 FDA.gov
FDA Decision Cleared SESE
Date Received January 11, 1996
Decision Date March 21, 1996
Days to Decision 70 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement

Device Classification

Product Code IZG — System, X-ray, Photofluorographic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1730

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