CALYPSO SYSTEM— 510(k) K120564

Substantially Equivalent

Hogan Lovells US LLP

FDA 510(k) clearance K120564 for CALYPSO SYSTEM, Substantially Equivalent on 2012-07-16. Applicant: Hogan Lovells US LLP.

Clearance details

Applicant: Hogan Lovells US LLP
Product code: Code NKB
Advisory panel: Orthopedic
Date received: 2012-02-24
Decision date: 2012-07-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Philedelphia, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code NKB

product code NKB

Death: 27
Injury: 5,033
Malfunction: 4,140
Total: 9,200

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.