Sniper (R) Spine System— 510(k) K160003

Substantially Equivalent

Spine Wave, Inc.

FDA 510(k) clearance K160003 for Sniper (R) Spine System, Substantially Equivalent on 2016-02-26. Applicant: Spine Wave, Inc..

Clearance details

Applicant: Spine Wave, Inc.
Product code: Code MNI
Advisory panel: Orthopedic
Date received: 2016-01-04
Decision date: 2016-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shelton, CT, 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.