MAKO SURGICAL CORPORATION UNICONDYLAR KNEE IMPLANT SYSTEM III— 510(k) K082081

Substantially Equivalent

Mako Surgical Corp.

FDA 510(k) clearance K082081 for MAKO SURGICAL CORPORATION UNICONDYLAR KNEE IMPLANT SYSTEM III, Substantially Equivalent on 2008-10-15. Applicant: Mako Surgical Corp..

Clearance details

Applicant: Mako Surgical Corp.
Product code: Code HSX
Advisory panel: Orthopedic
Date received: 2008-07-23
Decision date: 2008-10-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Lauderdale, 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.