SKY BONE EXPANDER SYSTEM (SKY SYSTEM)— 510(k) K040939

Substantially Equivalent

Disc-O-Tech Medical Technologies, Ltd.

FDA 510(k) clearance K040939 for SKY BONE EXPANDER SYSTEM (SKY SYSTEM), Substantially Equivalent on 2004-05-12. Applicant: Disc-O-Tech Medical Technologies, Ltd..

Clearance details

Applicant: Disc-O-Tech Medical Technologies, Ltd.
Product code: Code HRX
Advisory panel: Orthopedic
Date received: 2004-04-12
Decision date: 2004-05-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Herzliya, IL

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Adverse events under product code HRX

product code HRX

Injury: 623
Malfunction: 11,257
Total: 11,880

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.