SEATTLE II TOTAL HIP SYSTEM— 510(k) K812669

Name: FDA 510(k) clearance K812669
Creator: U.S. Food and Drug Administration
Published: 1981-10-02

Substantially Equivalent

Hexcel Medical

FDA 510(k) clearance K812669 for SEATTLE II TOTAL HIP SYSTEM, Substantially Equivalent on 1981-10-02. 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: 1981-09-21
Decision date: 1981-10-02
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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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

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K840416 — HEXCELITE1984-03-23
K820890 — URETHANE ORTHOPAEDIC CASTING TAPE1982-06-23
K812687 — BRIGHAM II TOTAL HIP SYSTEM1981-10-02
K812068 — PROPOSED CONTROLS FOR DOSIMETRIC RELEASE1981-09-08
K811164 — URETHANE ORTHOPAEDIC CASTING TAPE1981-05-27

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.