ZUMA, MODEL 55-XXXX/56-XXXX— 510(k) K082926

Substantially Equivalent

Seaspine, Inc.

FDA 510(k) clearance K082926 for ZUMA, MODEL 55-XXXX/56-XXXX, Substantially Equivalent on 2008-12-22. Applicant: Seaspine, Inc..

Clearance details

Applicant: Seaspine, Inc.
Product code: Code OVD
Advisory panel: Orthopedic
Date received: 2008-10-01
Decision date: 2008-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vista, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OVD

product code OVD

Death: 5
Injury: 495
Total: 500

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.