Cleared Traditional

ASFORA ANTERIOR CERVICAL PLATE SYSTEM, ONE LEVEL, 14MM ASFORA ANTERIOR CERVICAL PLATE SYSTEM, ONE LEVEL, 16MM

K122497 · Medical Design, LLC · Orthopedic

Oct 2012

Decision

60d

Days

Class 2

Risk

About This 510(k) Submission

K122497 is an FDA 510(k) clearance for the ASFORA ANTERIOR CERVICAL PLATE SYSTEM, ONE LEVEL, 14MM ASFORA ANTERIOR CERVICAL PLATE SYSTEM, ONE LEVEL, 16MM, a Appliance, Fixation, Spinal Intervertebral Body (Class II — Special Controls, product code KWQ), submitted by Medical Design, LLC (Sioux Falls, US). The FDA issued a Cleared decision on October 15, 2012, 60 days after receiving the submission on August 16, 2012. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number	K122497 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 16, 2012
Decision Date	October 15, 2012
Days to Decision	60 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF