PRECICE Intramedullary Limb Lengthening System— 510(k) K151131

Substantially Equivalent

Ellipse Technologies, Incorporated

FDA 510(k) clearance K151131 for PRECICE Intramedullary Limb Lengthening System, Substantially Equivalent on 2015-06-19. Applicant: Ellipse Technologies, Incorporated.

Clearance details

Applicant: Ellipse Technologies, Incorporated
Product code: Code HSB
Advisory panel: Orthopedic
Date received: 2015-04-28
Decision date: 2015-06-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Irvine, CA, 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.