12-9170 SERIES II TOTAL HIP— 510(k) K761243

Name: FDA 510(k) clearance K761243
Creator: U.S. Food and Drug Administration
Published: 1976-12-16

Substantially Equivalent

Richardo Manufacturing Co.

FDA 510(k) clearance K761243 for 12-9170 SERIES II TOTAL HIP, Substantially Equivalent on 1976-12-16. Applicant: Richardo Manufacturing Co.. Device class: 2.

Clearance details

Applicant: Richardo Manufacturing Co.
Product code: Code JDG
Device class: Class 2
Regulation: 21 CFR 888.3360
Advisory panel: Orthopedic
Date received: 1976-12-13
Decision date: 1976-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Recent devices under product code JDG

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K212431 — Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve2022-02-07
K193546 — Distal Centralizers2020-09-25
K173499 — Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads2018-03-19
K001984 — PROGENY FORGED COCR CEMENTED FEMORAL COMPONENT2000-09-27
K992234 — THE TAPER-FIT TOTAL HIP SYSTEM1999-11-10

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.