TF-II HIP PROSTHESIS— 510(k) K843995

Name: FDA 510(k) clearance K843995
Creator: U.S. Food and Drug Administration
Published: 1985-04-23

Substantially Equivalent

Dow Corning Corp. Healthcare Industries Materials

FDA 510(k) clearance K843995 for TF-II HIP PROSTHESIS, Substantially Equivalent on 1985-04-23. 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: 1984-10-11
Decision date: 1985-04-23
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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K260536 — Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement2026-05-15
K253675 — OsteoRemedies Hip Spacer System2025-12-23
K252326 — InterSpace GV Hip Spacer2025-08-06
K242865 — Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer2025-06-12

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
K842559 — WHITESIDE ORTHOLOC TOTAL HIP FEMORAL1984-12-20
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.