MAKO SURGICAL UNICONDYLAR KNEE SYSTEM— 510(k) K060017

Substantially Equivalent

Mako Surgical Corp.

FDA 510(k) clearance K060017 for MAKO SURGICAL UNICONDYLAR KNEE SYSTEM, Substantially Equivalent on 2006-02-23. Applicant: Mako Surgical Corp..

Clearance details

Applicant: Mako Surgical Corp.
Product code: Code HSX
Advisory panel: Orthopedic
Date received: 2006-01-04
Decision date: 2006-02-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hollywood, FL, US

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Adverse events under product code HSX

product code HSX

Injury: 1,003
Other: 1
Total: 1,004

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.