MALIBU SPINAL SYSTEM

Thoracolumbosacral Pedicle Screw System

SEASPINE, INC.

The following data is part of a premarket notification filed by Seaspine, Inc. with the FDA for Malibu Spinal System.

Pre-market Notification Details

• Device ID: K061342
• 510k Number: K061342
• Device Name: MALIBU SPINAL SYSTEM
• Classification: Thoracolumbosacral Pedicle Screw System
• Applicant: SEASPINE, INC. 2302 LA MIRADA DR. Vista, CA 92081 -7862
• Contact: Diana Smith
• Correspondent: Diana Smith; SEASPINE, INC. 2302 LA MIRADA DR. Vista, CA 92081 -7862
• Product Code: NKB
• Subsequent Product Code: KWP
• Subsequent Product Code: MNH
• Subsequent Product Code: MNI
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-04-15
• Decision Date: 2006-10-25
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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