ZIRCONIA CERAMIC HEAD (YITRIA STABILIZED)— 510(k) K885069

Name: FDA 510(k) clearance K885069
Creator: U.S. Food and Drug Administration
Published: 1989-09-01

Substantially Equivalent for Some Indications

Richards Medical Co., Inc.

FDA 510(k) clearance K885069 for ZIRCONIA CERAMIC HEAD (YITRIA STABILIZED), Substantially Equivalent for Some Indications on 1989-09-01. Applicant: Richards Medical Co., Inc.. Device class: 2.

Clearance details

Applicant: Richards Medical Co., Inc.
Product code: Code LZO
Device class: Class 2
Regulation: 21 CFR 888.3353
Advisory panel: Orthopedic
Date received: 1988-12-08
Decision date: 1989-09-01
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Memphis, TN, US

Download summary PDF View on FDA.gov ↗

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K896106 — ROGOZINSKI SPINAL SYSTEM, ADD'L COMPONENTS1990-06-25
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K895241 — INTRAMEDULLARY HIP SCREW1990-01-04
K884824 — TRICON-M TOTAL KNEE SYSTEM1989-11-21

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.