ORTHOMET TITANIUM HYBRID FEMORAL STEM— 510(k) K945783

Name: FDA 510(k) clearance K945783
Creator: U.S. Food and Drug Administration
Published: 1995-05-30

Substantially Equivalent

Orthomet, Inc.

FDA 510(k) clearance K945783 for ORTHOMET TITANIUM HYBRID FEMORAL STEM, Substantially Equivalent on 1995-05-30. Applicant: Orthomet, Inc.. Device class: 2.

Clearance details

Applicant: Orthomet, Inc.
Product code: Code JDG
Device class: Class 2
Regulation: 21 CFR 888.3360
Advisory panel: Orthopedic
Date received: 1994-11-25
Decision date: 1995-05-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, 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 Orthomet, Inc.

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K936310 — ORTHOMET HMC FEMORAL STEM COMPONENT1995-06-07
K943873 — ORTHOMET ANATOMICALLY GUIDED CARPAL TUNNEL RELEASE SY1995-04-26
K944752 — ORTHOMET RESURFACING FEMORAL COMPONENT1994-12-28
K930771 — PERFECTA TOTAL HIP SYSTEM COATED COCR FEMORAL STEM1994-11-30
K926334 — AXIOM TOTAL KNEE SYST/ACL RETAIN TIBIAL TRAY/INSER1994-10-18

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.