ZUMA

Spinal Vertebral Body Replacement Device

SEASPINE, INC.

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

Pre-market Notification Details

• Device ID: K071726
• 510k Number: K071726
• Device Name: ZUMA
• Classification: Spinal Vertebral Body Replacement Device
• Applicant: SEASPINE, INC. 2302 LA MIRADA DR. Vista, CA 92081 -7862
• Contact: Ethel Bernal
• Correspondent: Ethel Bernal; SEASPINE, INC. 2302 LA MIRADA DR. Vista, CA 92081 -7862
• Product Code: MQP
• CFR Regulation Number: 888.3060 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-06-25
• Decision Date: 2007-10-23
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10889981037154	K071726	000
10889981037307	K071726	000
10889981037314	K071726	000
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