Cleared Traditional

BONE GRAFT WASHER, MODEL 9090114 - 9090118

K994122 · Danek Medical, Inc. · Orthopedic
Feb 2000
Decision
73d
Days
Class 2
Risk

About This 510(k) Submission

K994122 is an FDA 510(k) clearance for the BONE GRAFT WASHER, MODEL 9090114 - 9090118, a Appliance, Fixation, Spinal Intervertebral Body (Class II — Special Controls, product code KWQ), submitted by Danek Medical, Inc. (Memphis, US). The FDA issued a Cleared decision on February 18, 2000, 73 days after receiving the submission on December 7, 1999. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number K994122 FDA.gov
FDA Decision Cleared SESE
Date Received December 07, 1999
Decision Date February 18, 2000
Days to Decision 73 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code KWQ — Appliance, Fixation, Spinal Intervertebral Body
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3060

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