K061607

Substantially Equivalent

STORM OPERATING KIT, MODEL 1-10-0

Applicant: Intelligent Orthopaedics, Ltd.
Product code: HTY
Advisory panel: Orthopedic
Date received: 2006-06-09
Decision date: 2006-07-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brierfield, Nelson, GB

Adverse events under product code HTY

product code HTY

Injury: 544
Total: 544

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.