Cleared Traditional

RAY SACRAL FIXATION SYSTEM

K904520 · Danek Medical, Inc. · Orthopedic
Oct 1991
Decision
387d
Days
Class 2
Risk

About This 510(k) Submission

K904520 is an FDA 510(k) clearance for the RAY SACRAL FIXATION SYSTEM, a Appliance, Fixation, Spinal Interlaminal (Class II — Special Controls, product code KWP), submitted by Danek Medical, Inc. (Memphis, US). The FDA issued a Cleared decision on October 25, 1991, 387 days after receiving the submission on October 3, 1990. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3050.

Submission Details

510(k) Number K904520 FDA.gov
FDA Decision Cleared SN
Date Received October 03, 1990
Decision Date October 25, 1991
Days to Decision 387 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary —

Device Classification

Product Code KWP — Appliance, Fixation, Spinal Interlaminal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3050

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