4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM

Orthosis, Spondylolisthesis Spinal Fixation

SOLCO BIOMEDICAL CO., LTD.

The following data is part of a premarket notification filed by Solco Biomedical Co., Ltd. with the FDA for 4cis Solar Spine System And 4cis Apollon Spine System.

Pre-market Notification Details

• Device ID: K050471
• 510k Number: K050471
• Device Name: 4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM
• Classification: Orthosis, Spondylolisthesis Spinal Fixation
• Applicant: SOLCO BIOMEDICAL CO., LTD. 7612 BARNUM ROAD Bethesda, MD 20817
• Contact: Saeyoung Ahn
• Correspondent: Saeyoung Ahn; SOLCO BIOMEDICAL CO., LTD. 7612 BARNUM ROAD Bethesda, MD 20817
• Product Code: MNH
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2005-02-23
• Decision Date: 2005-05-12
• Summary: summary

NIH GUDID Devices

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