K912985

Substantially Equivalent

LIMA 28MM CERAMIC HEAD, MODIFICATION

Applicant: Turnkey Intergration USA, Inc.
Product code: LZO
Advisory panel: Orthopedic
Date received: 1991-07-02
Decision date: 1991-12-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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.