ASPIRON ACP SYSTEM

Appliance, Fixation, Spinal Intervertebral Body

U&I CORP.

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

Pre-market Notification Details

• Device ID: K140234
• 510k Number: K140234
• Device Name: ASPIRON ACP SYSTEM
• Classification: Appliance, Fixation, Spinal Intervertebral Body
• Applicant: U&I CORP. 20, Sandan-ro 76beon-gil(Rd) Uijeongbu-si, KR 480-859
• Contact: Young-geun Kim
• Correspondent: Young-geun Kim; U&I CORP. 20, Sandan-ro 76beon-gil(Rd) Uijeongbu-si, 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: 2014-01-29
• Decision Date: 2014-06-02
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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