4CIS PEEK, PLIF AND TLIF CAGE SYSTEM

Intervertebral Fusion Device With Bone Graft, Lumbar

SOLCO BIOMEDICAL CO., LTD.

The following data is part of a premarket notification filed by Solco Biomedical Co., Ltd. with the FDA for 4cis Peek, Plif And Tlif Cage System.

Pre-market Notification Details

• Device ID: K092162
• 510k Number: K092162
• Device Name: 4CIS PEEK, PLIF AND TLIF CAGE SYSTEM
• Classification: Intervertebral Fusion Device With Bone Graft, Lumbar
• Applicant: SOLCO BIOMEDICAL CO., LTD. 155 GIBBS ST., SUITE 510 Rockville, MD 20850
• Contact: Saeyoung Ahn
• Correspondent: Saeyoung Ahn; SOLCO BIOMEDICAL CO., LTD. 155 GIBBS ST., SUITE 510 Rockville, MD 20850
• Product Code: MAX
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-07-16
• Decision Date: 2010-01-06
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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