Cleared Traditional

ROGOZINSKI SPINAL SYSTEM, ADD'L COMPONENTS

K896106 · Richards Medical Co., Inc. · Orthopedic
Jun 1990
Decision
248d
Days
Class 2
Risk

About This 510(k) Submission

K896106 is an FDA 510(k) clearance for the ROGOZINSKI SPINAL SYSTEM, ADD'L COMPONENTS, a Appliance, Fixation, Spinal Interlaminal (Class II — Special Controls, product code KWP), submitted by Richards Medical Co., Inc. (Memphus, US). The FDA issued a Cleared decision on June 25, 1990, 248 days after receiving the submission on October 20, 1989. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3050.

Submission Details

510(k) Number K896106 FDA.gov
FDA Decision Cleared SN
Date Received October 20, 1989
Decision Date June 25, 1990
Days to Decision 248 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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