ISKD (INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR)— 510(k) K010322

Substantially Equivalent

Orthodyne, Inc.

FDA 510(k) clearance K010322 for ISKD (INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR), Substantially Equivalent on 2001-05-02. Applicant: Orthodyne, Inc..

Clearance details

Applicant: Orthodyne, Inc.
Product code: Code HSB
Advisory panel: Orthopedic
Date received: 2001-02-02
Decision date: 2001-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orlando, FL, US

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Adverse events under product code HSB

product code HSB

Death: 49
Injury: 12,083
Malfunction: 6,561
Other: 1
Total: 18,694

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.