CONSENSUS(TM) TOTAL HIP SYSTEM— 510(k) K922561

Name: FDA 510(k) clearance K922561
Creator: U.S. Food and Drug Administration
Published: 1993-07-21

Substantially Equivalent

U.S. Medical Products, Inc.

FDA 510(k) clearance K922561 for CONSENSUS(TM) TOTAL HIP SYSTEM, Substantially Equivalent on 1993-07-21. Applicant: U.S. Medical Products, Inc.. Device class: 3.

Clearance details

Applicant: U.S. Medical Products, Inc.
Product code: Code JDL
Device class: Class 3
Regulation: 21 CFR 888.3320
Advisory panel: Orthopedic
Date received: 1992-06-03
Decision date: 1993-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

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K051995 — PROFEMUR RENAISSANCE HIP STEM2005-08-22
K051348 — CONSERVE TOTAL FEMORAL HEAD2005-08-19

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Adverse events under product code JDL

product code JDL

Injury: 285
Total: 285

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.