HEXCEL FEMORAL COMPONENT HIP PROSTHESIS— 510(k) K800051

Name: FDA 510(k) clearance K800051
Creator: U.S. Food and Drug Administration
Published: 1980-01-28

Substantially Equivalent

Hexcel Medical

FDA 510(k) clearance K800051 for HEXCEL FEMORAL COMPONENT HIP PROSTHESIS, Substantially Equivalent on 1980-01-28. Applicant: Hexcel Medical. Device class: 2.

Clearance details

Applicant: Hexcel Medical
Product code: Code JDG
Device class: Class 2
Regulation: 21 CFR 888.3360
Advisory panel: Orthopedic
Date received: 1980-01-09
Decision date: 1980-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JDG

view all

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 Hexcel Medical

view all

K840416 — HEXCELITE1984-03-23
K820890 — URETHANE ORTHOPAEDIC CASTING TAPE1982-06-23
K812669 — SEATTLE II TOTAL HIP SYSTEM1981-10-02
K812687 — BRIGHAM II TOTAL HIP SYSTEM1981-10-02
K812068 — PROPOSED CONTROLS FOR DOSIMETRIC RELEASE1981-09-08

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.