PRESSURIZING/SCAVENGING ACRYLIC CEMENT— 510(k) K840046

Name: FDA 510(k) clearance K840046
Creator: U.S. Food and Drug Administration
Published: 1984-02-09

Substantially Equivalent

Precision Medical Devices, Inc.

FDA 510(k) clearance K840046 for PRESSURIZING/SCAVENGING ACRYLIC CEMENT, Substantially Equivalent on 1984-02-09. Applicant: Precision Medical Devices, Inc.. Device class: 1.

Clearance details

Applicant: Precision Medical Devices, Inc.
Product code: Code KIH
Device class: Class 1
Regulation: 21 CFR 888.4200
Advisory panel: Orthopedic
Date received: 1984-01-06
Decision date: 1984-02-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K863854 — P.M.D. INTRAMEDULLARY CEMENT RESTRICTOR PLUG1986-11-19
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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.