Cleared Traditional

CROSSLINK PLATE

K911307 · Danek Medical, Inc. · Orthopedic
Oct 1991
Decision
213d
Days
Class 2
Risk

About This 510(k) Submission

K911307 is an FDA 510(k) clearance for the CROSSLINK PLATE, 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 24, 1991, 213 days after receiving the submission on March 25, 1991. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3050.

Submission Details

510(k) Number K911307 FDA.gov
FDA Decision Cleared SESE
Date Received March 25, 1991
Decision Date October 24, 1991
Days to Decision 213 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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