ZIRCONIA CERAMIC HEAD ADD'L SIZES— 510(k) K896204

Substantially Equivalent for Some Indications

Richards Medical Co., Inc.

FDA 510(k) clearance K896204 for ZIRCONIA CERAMIC HEAD ADD'L SIZES, Substantially Equivalent for Some Indications on 1989-11-20. Applicant: Richards Medical Co., Inc..

Clearance details

Applicant: Richards Medical Co., Inc.
Product code: Code LZO
Advisory panel: Orthopedic
Date received: 1989-10-26
Decision date: 1989-11-20
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Memphis, TN, US

Download summary PDF View on FDA.gov ↗

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.