PLATE BLADE WITH CURSOR OF L'UNION— 510(k) K911021

Name: FDA 510(k) clearance K911021
Creator: U.S. Food and Drug Administration
Published: 1991-05-29

Substantially Equivalent

Sport Service, Inc.

FDA 510(k) clearance K911021 for PLATE BLADE WITH CURSOR OF L'UNION, Substantially Equivalent on 1991-05-29. Applicant: Sport Service, Inc.. Device class: 2.

Clearance details

Applicant: Sport Service, Inc.
Product code: Code KTT
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 1991-03-01
Decision date: 1991-05-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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More clearances from Sport Service, Inc.

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K911020 — LIGAMENTOPLASTIC STAPLE OF L'UNION1991-05-29
K911026 — STAPLE BLADE FOR TIBIAL OSTEO/STAPLE BLADE L'UNION1991-05-29
K911031 — THE TRAMOND PIN1991-05-29

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.