MERIDIAN TITANIUM FEMORAL STEMS— 510(k) K972228

Substantially Equivalent for Some Indications

Howmedica, Inc.

FDA 510(k) clearance K972228 for MERIDIAN TITANIUM FEMORAL STEMS, Substantially Equivalent for Some Indications on 1997-12-05. Applicant: Howmedica, Inc..

Clearance details

Applicant: Howmedica, Inc.
Product code: Code LZO
Advisory panel: Orthopedic
Date received: 1997-06-13
Decision date: 1997-12-05
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Rutherford, NJ, 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.