PROSTHESIS, TOTAL HIP-TEST FEMORAL— 510(k) K760107

Name: FDA 510(k) clearance K760107
Creator: U.S. Food and Drug Administration
Published: 1976-07-20

Substantially Equivalent

Orthopedic Equipment Co., Inc.

FDA 510(k) clearance K760107 for PROSTHESIS, TOTAL HIP-TEST FEMORAL, Substantially Equivalent on 1976-07-20. Applicant: Orthopedic Equipment Co., Inc.. Device class: 2.

Clearance details

Applicant: Orthopedic Equipment Co., Inc.
Product code: Code JDG
Device class: Class 2
Regulation: 21 CFR 888.3360
Advisory panel: Orthopedic
Date received: 1976-06-24
Decision date: 1976-07-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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

More clearances from Orthopedic Equipment Co., Inc.

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K834035 — UNIVERSAL SELF-ALIGNING ACETABULAR COM1984-06-19
K841189 — OEC/REZAIAN SPINAL FIXATOR1984-05-16
K800530 — SCHLEIN TRI-SURFACE ANKLE1980-04-02
K781445 — SPREADER1979-09-27
K790209 — FILTER SYSTEM, ALTNER DISPOSABLE1979-02-26

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.