Cleared Traditional

ROGOZINSKI SPINAL SYSTEM

K884263 · Richards Medical Co., Inc. · Orthopedic
Dec 1988
Decision
79d
Days
Class 2
Risk

About This 510(k) Submission

K884263 is an FDA 510(k) clearance for the ROGOZINSKI SPINAL SYSTEM, 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 December 29, 1988, 79 days after receiving the submission on October 11, 1988. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3050.

Submission Details

510(k) Number K884263 FDA.gov
FDA Decision Cleared SESE
Date Received October 11, 1988
Decision Date December 29, 1988
Days to Decision 79 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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