ZUMA-C

Intervertebral Fusion Device With Integrated Fixation, Cervical

SEASPINE, INC.

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

Pre-market Notification Details

• Device ID: K092521
• 510k Number: K092521
• Device Name: ZUMA-C
• Classification: Intervertebral Fusion Device With Integrated Fixation, Cervical
• 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: OVE
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-08-18
• Decision Date: 2010-04-13
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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