CARDO MEDICAL CERAMIC HIP SYSTEM— 510(k) K100008

Name: FDA 510(k) clearance K100008
Creator: U.S. Food and Drug Administration
Published: 2010-05-18

Substantially Equivalent

Cardo Medical, Inc.

FDA 510(k) clearance K100008 for CARDO MEDICAL CERAMIC HIP SYSTEM, Substantially Equivalent on 2010-05-18. Applicant: Cardo Medical, Inc.. Device class: 2.

Clearance details

Applicant: Cardo Medical, Inc.
Product code: Code LZO
Device class: Class 2
Regulation: 21 CFR 888.3353
Advisory panel: Orthopedic
Date received: 2010-01-04
Decision date: 2010-05-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clifton, NJ, US

Download summary PDF View on FDA.gov ↗

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K260037 — implantcast Packaging System Update2026-03-30

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K101032 — CARDO MEDICAL FEMORAL CEMENT RESTRICTOR, MODEL 503-MCRX2010-07-08

Adverse events under product code LZO

product code LZO

Death: 17
Injury: 12,942
Malfunction: 1,756
Total: 14,715

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.