REPROCESSED EXTERNAL FIXATION DEVICE— 510(k) K051957

Name: FDA 510(k) clearance K051957
Creator: U.S. Food and Drug Administration
Published: 2005-09-21

Substantially Equivalent

Sterilemed, Inc.

FDA 510(k) clearance K051957 for REPROCESSED EXTERNAL FIXATION DEVICE, Substantially Equivalent on 2005-09-21. Applicant: Sterilemed, Inc.. Device class: 2.

Clearance details

Applicant: Sterilemed, Inc.
Product code: Code KTT
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2005-07-15
Decision date: 2005-09-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Maple Grove, MN, US

Download summary PDF View on FDA.gov ↗

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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.