ACCIN UNI-KNEE SYSTEM— 510(k) K063782

Substantially Equivalent

Accin Corporation

FDA 510(k) clearance K063782 for ACCIN UNI-KNEE SYSTEM, Substantially Equivalent on 2007-01-19. Applicant: Accin Corporation.

Clearance details

Applicant: Accin Corporation
Product code: Code HSX
Advisory panel: Orthopedic
Date received: 2006-12-21
Decision date: 2007-01-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Clifton, NJ, 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.