Cleared Traditional

CAYMAN LP Plate System

K190584 · K2m, Inc. · Orthopedic
May 2019
Decision
70d
Days
Class 2
Risk

About This 510(k) Submission

K190584 is an FDA 510(k) clearance for the CAYMAN LP Plate System, a Appliance, Fixation, Spinal Intervertebral Body (Class II — Special Controls, product code KWQ), submitted by K2m, Inc. (Leesburg, US). The FDA issued a Cleared decision on May 15, 2019, 70 days after receiving the submission on March 6, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number K190584 FDA.gov
FDA Decision Cleared SESE
Date Received March 06, 2019
Decision Date May 15, 2019
Days to Decision 70 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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