GUARDIAN INFLATABLE BONE EXPANDER SYSTEM— 510(k) K111593

Substantially Equivalent

Bm Korea Co., Ltd.

FDA 510(k) clearance K111593 for GUARDIAN INFLATABLE BONE EXPANDER SYSTEM, Substantially Equivalent on 2011-11-18. Applicant: Bm Korea Co., Ltd..

Clearance details

Applicant: Bm Korea Co., Ltd.
Product code: Code NDN
Advisory panel: Orthopedic
Date received: 2011-06-07
Decision date: 2011-11-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marietta, GA, US

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Adverse events under product code NDN

product code NDN

Death: 24
Injury: 407
Malfunction: 1,975
Total: 2,406

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.