MINI RAIL EXTERNAL FIXATOR SYSTEM— 510(k) K093550

Substantially Equivalent

Small Bone Innovations, Inc.

FDA 510(k) clearance K093550 for MINI RAIL EXTERNAL FIXATOR SYSTEM, Substantially Equivalent on 2010-01-07. Applicant: Small Bone Innovations, Inc..

Clearance details

Applicant: Small Bone Innovations, Inc.
Product code: Code KTT
Advisory panel: Orthopedic
Date received: 2009-11-17
Decision date: 2010-01-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Morrisville, PA, US

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Adverse events under product code KTT

product code KTT

Death: 11
Injury: 3,097
Malfunction: 1,261
Total: 4,369

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.