SNN SYSTEM WITH OLIVIER DOUBLE CHUCK SUPPORT ARM OPTION— 510(k) K992457

Substantially Equivalent

Surgical Navigation Specialists, Inc.

FDA 510(k) clearance K992457 for SNN SYSTEM WITH OLIVIER DOUBLE CHUCK SUPPORT ARM OPTION, Substantially Equivalent on 1999-08-27. Applicant: Surgical Navigation Specialists, Inc..

Clearance details

Applicant: Surgical Navigation Specialists, Inc.
Product code: Code HAW
Advisory panel: Neurology
Date received: 1999-07-23
Decision date: 1999-08-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mississauga Ontario, CA

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Adverse events under product code HAW

product code HAW

Death: 52
Injury: 1,083
Malfunction: 17,300
Total: 18,435

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.