ASPIRON ACP SYSTEM

Appliance, Fixation, Spinal Intervertebral Body

U & I CORPORATION

The following data is part of a premarket notification filed by U & I Corporation with the FDA for Aspiron Acp System.

Pre-market Notification Details

• Device ID: K131200
• 510k Number: K131200
• Device Name: ASPIRON ACP SYSTEM
• Classification: Appliance, Fixation, Spinal Intervertebral Body
• Applicant: U & I CORPORATION 20, SANDAN-RO, 76BEON-GIL (RD) Uijeongbu-si, Gyeonggi-do, KR 480-859
• Contact: Gyeong-je Kwon
• Correspondent: Gyeong-je Kwon; U & I CORPORATION 20, SANDAN-RO, 76BEON-GIL (RD) Uijeongbu-si, Gyeonggi-do, KR 480-859
• Product Code: KWQ
• CFR Regulation Number: 888.3060 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-04-29
• Decision Date: 2013-08-29
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
08800015911368	K131200	000
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