WHITESIDE ORTHOLOC TOTAL HIP FEMORAL— 510(k) K842559

Name: FDA 510(k) clearance K842559
Creator: U.S. Food and Drug Administration
Published: 1984-12-20

Substantially Equivalent

Dow Corning Corp. Healthcare Industries Materials

FDA 510(k) clearance K842559 for WHITESIDE ORTHOLOC TOTAL HIP FEMORAL, Substantially Equivalent on 1984-12-20. Applicant: Dow Corning Corp. Healthcare Industries Materials. Device class: 2.

Clearance details

Applicant: Dow Corning Corp. Healthcare Industries Materials
Product code: Code KWL
Device class: Class 2
Regulation: 21 CFR 888.3360
Advisory panel: Orthopedic
Date received: 1984-07-02
Decision date: 1984-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: P.O. Box 1767 Midland, MI, US

Download summary PDF View on FDA.gov ↗

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More clearances from Dow Corning Corp. Healthcare Industries Materials

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K853186 — SILASTIC INFLATABLE BONE PLUG H.P.1985-09-24
K844637 — WHITESIDE ACRYLIC CEMENT SPACER SLEEVE1985-06-19
K850255 — DOW CORNING WRIGHT TITANIUM WRIST JOINT GROMMET1985-05-01
K843995 — TF-II HIP PROSTHESIS1985-04-23
K840357 — SSA HIP PROSTHESIS1984-02-17

Adverse events under product code KWL

product code KWL

Injury: 523
Total: 523

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.