VOYAGER LINUX WITH TACTILE GUIDANCE SYSTEM (TGS)— 510(k) K052851

Substantially Equivalent

Mako Surgical Corp.

FDA 510(k) clearance K052851 for VOYAGER LINUX WITH TACTILE GUIDANCE SYSTEM (TGS), Substantially Equivalent on 2005-11-18. Applicant: Mako Surgical Corp..

Clearance details

Applicant: Mako Surgical Corp.
Product code: Code HAW
Advisory panel: Neurology
Date received: 2005-10-11
Decision date: 2005-11-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Hollywood, FL, US

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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.