PROXIMAL FEMORAL REPLACEMENT PROSTHESIS— 510(k) K874575

Name: FDA 510(k) clearance K874575
Creator: U.S. Food and Drug Administration
Published: 1988-01-07

Substantially Equivalent

Dow Corning Wright

FDA 510(k) clearance K874575 for PROXIMAL FEMORAL REPLACEMENT PROSTHESIS, Substantially Equivalent on 1988-01-07. Applicant: Dow Corning Wright. Device class: 2.

Clearance details

Applicant: Dow Corning Wright
Product code: Code JDG
Device class: Class 2
Regulation: 21 CFR 888.3360
Advisory panel: Orthopedic
Date received: 1987-11-06
Decision date: 1988-01-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arlington, TN, US

Download summary PDF View on FDA.gov ↗

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K934354 — LACEY ALL POLYETHYLENE TIBIAL COMPONENT1994-06-03
K932222 — SLT FEMORAL HEAD1994-05-27
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Adverse events under product code JDG

product code JDG

Injury: 804
Malfunction: 3,242
Total: 4,046

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.