Cleared Traditional

K131200 - ASPIRON ACP SYSTEM
(FDA 510(k) Clearance)

K131200 · U&I Corporation · Orthopedic

Aug 2013

Decision

122d

Days

Class 2

Risk

K131200 is an FDA 510(k) clearance for the ASPIRON ACP SYSTEM. This device is classified as a Appliance, Fixation, Spinal Intervertebral Body (Class II — Special Controls, product code KWQ).

Submitted by U&I Corporation (Uijeongbu-Si, Gyeonggi-Do, KR). The FDA issued a Cleared decision on August 29, 2013, 122 days after receiving the submission on April 29, 2013.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number	K131200 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 29, 2013
Decision Date	August 29, 2013
Days to Decision	122 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF