Cleared Traditional

TAYLOR SPINAL RETRACTOR

K892546 · Zinnanti Surgical Instruments, Inc. · Neurology
May 1989
Decision
30d
Days
Class 1
Risk

About This 510(k) Submission

K892546 is an FDA 510(k) clearance for the TAYLOR SPINAL RETRACTOR, a Instrument, Surgical, Non-powered (Class I — General Controls, product code HAO), submitted by Zinnanti Surgical Instruments, Inc. (Chatsworth, US). The FDA issued a Cleared decision on May 11, 1989, 30 days after receiving the submission on April 11, 1989. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4535.

Submission Details

510(k) Number K892546 FDA.gov
FDA Decision Cleared SESE
Date Received April 11, 1989
Decision Date May 11, 1989
Days to Decision 30 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary —

Device Classification

Product Code HAO — Instrument, Surgical, Non-powered
Device Class Class I — General Controls
CFR Regulation 21 CFR 882.4535

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