Cleared Traditional

TSRH OPEN HEAD BONE SCREW

K911319 · Danek Medical, Inc. · Orthopedic
Sep 1991
Decision
164d
Days
Class 2
Risk

About This 510(k) Submission

K911319 is an FDA 510(k) clearance for the TSRH OPEN HEAD BONE SCREW, 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 September 6, 1991, 164 days after receiving the submission on March 26, 1991. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3050.

Submission Details

510(k) Number K911319 FDA.gov
FDA Decision Cleared SESE
Date Received March 26, 1991
Decision Date September 06, 1991
Days to Decision 164 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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