ACUMED SMALL BONE LOCKING SYSTEM II— 510(k) K071944

Substantially Equivalent

Acumed, LLC

FDA 510(k) clearance K071944 for ACUMED SMALL BONE LOCKING SYSTEM II, Substantially Equivalent on 2007-08-09. Applicant: Acumed, LLC.

Clearance details

Applicant: Acumed, LLC
Product code: Code HSB
Advisory panel: Orthopedic
Date received: 2007-07-13
Decision date: 2007-08-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Hillsboro, OR, 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.