SIERRA— 510(k) K062934

Substantially Equivalent

Seaspine, Inc.

FDA 510(k) clearance K062934 for SIERRA, Substantially Equivalent on 2006-11-16. Applicant: Seaspine, Inc..

Clearance details

Applicant: Seaspine, Inc.
Product code: Code MNI
Advisory panel: Orthopedic
Date received: 2006-09-28
Decision date: 2006-11-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vista, CA, US

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Adverse events under product code MNI

product code MNI

Injury: 641
Total: 641

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.