GUN, CEMENT— 510(k) K781955

Name: FDA 510(k) clearance K781955
Creator: U.S. Food and Drug Administration
Published: 1978-12-04

Substantially Equivalent

Depuy, Inc.

FDA 510(k) clearance K781955 for GUN, CEMENT, Substantially Equivalent on 1978-12-04. Applicant: Depuy, Inc.. Device class: 1.

Clearance details

Applicant: Depuy, Inc.
Product code: Code KIH
Device class: Class 1
Regulation: 21 CFR 888.4200
Advisory panel: Orthopedic
Date received: 1978-11-21
Decision date: 1978-12-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KIH

product code KIH

Death: 3
Total: 3

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.