SONOMA ANTERIOR CERVICAL PLATE SYSTEM

Appliance, Fixation, Spinal Intervertebral Body

SEASPINE

The following data is part of a premarket notification filed by Seaspine with the FDA for Sonoma Anterior Cervical Plate System.

Pre-market Notification Details

• Device ID: K032368
• 510k Number: K032368
• Device Name: SONOMA ANTERIOR CERVICAL PLATE SYSTEM
• Classification: Appliance, Fixation, Spinal Intervertebral Body
• Applicant: SEASPINE 727 PARK BLVD. San Diego, CA 92101
• Contact: Diana Smith
• Correspondent: Diana Smith; SEASPINE 727 PARK BLVD. San Diego, CA 92101
• Product Code: KWQ
• CFR Regulation Number: 888.3060 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-08-01
• Decision Date: 2003-10-09
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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