Cleared Traditional

MAXAN ANTERIOR CERVICAL PLATE SYSTEM

K133518 · Biomet Spine (Aka Ebi, LLC) · Orthopedic
Nov 2014
Decision
355d
Days
Class 2
Risk

About This 510(k) Submission

K133518 is an FDA 510(k) clearance for the MAXAN ANTERIOR CERVICAL PLATE SYSTEM, a Appliance, Fixation, Spinal Intervertebral Body (Class II — Special Controls, product code KWQ), submitted by Biomet Spine (Aka Ebi, LLC) (Parsippany, US). The FDA issued a Cleared decision on November 5, 2014, 355 days after receiving the submission on November 15, 2013. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number K133518 FDA.gov
FDA Decision Cleared SESE
Date Received November 15, 2013
Decision Date November 05, 2014
Days to Decision 355 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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