ANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL(A3 INTERLOCKING NAIL )— 510(k) K112982

Substantially Equivalent

Small Bone Innovations, Inc.

FDA 510(k) clearance K112982 for ANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL(A3 INTERLOCKING NAIL ), Substantially Equivalent on 2012-04-02. Applicant: Small Bone Innovations, Inc..

Clearance details

Applicant: Small Bone Innovations, Inc.
Product code: Code HSB
Advisory panel: Orthopedic
Date received: 2011-10-06
Decision date: 2012-04-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Morrisville, PA, 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.